Axial Spondyloarthritis

BIMZELX® (bimekizumab-bkzx) is now commercially available by prescription in the United States in a 2 mL prefilled syringe and autoinjector, each containing 320 mg of BIMZELX The single-injection device offers convenience for patients requiring a 320 mg dose of BIMZELX with single-injection administration ATLANTA, Jan. 16, 2025 /PRNewswire/ -- UCB, a global biopharmaceutical company, announced today that a single-injection 2 mL prefilled syringe and autoinjector, each containing 320 mg of BIMZELX® (bimekizumab-bkzx) is now available. These are in addition to the currently available 1 mL device administration options, each containing 160 mg of BIMZELX. With the new presentations, patients requiring a 320 mg dose of BIMZELX will have options for single-injection administration.1 "With five new FDA-approved indications for BIMZELX in just over a year, we've had the opportunity to reach a wider range of people living with chronic inflammatory conditions who have long been in need of new treatment options," said Camille Lee, Head of U.S. Immunology, UCB. "With the addition of a single-injection administration regimen, we are further expanding options and enhancing the treatment experience for individuals with moderate-to-severe plaque psoriasis, active psoriatic arthritis with coexistent moderate-to-severe plaque psoriasis, and moderate-to-severe hidradenitis suppurativa who receive a 320 mg dose of BIMZELX." The approval of the 320 mg single-injection administration option in October 2024 was supported by data from studies evaluating the bioequivalence of BIMZELX 320 mg given as one 2 mL subcutaneous injection, and BIMZELX 320 mg given as two 1 mL subcutaneous injections, in healthy study participants.1 In the U.S., the indications for BIMZELX where a 320 mg dose is recommended are adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis (PsA) with coexistent moderate-to-severe plaque psoriasis, and adults with moderate-to-severe hidradenitis suppurativa.1* In all other indications, adults with active PsA, adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS), a 160 mg dose is recommended.1 Through BIMZELX Navigate®, UCB offers tailored patient support to patients who have been prescribed BIMZELX. Upon enrollment, patients will be offered support from a dedicated Nurse Navigator. This licensed, registered nurse will be available to discuss treatment goals, provide training assistance to patients on how to administer BIMZELX, connect eligible patients to copay support, and keep patients up-to-date about their BIMZELX shipment and insurance coverage status. Patients who have been prescribed BIMZELX may enroll in BIMZELX Navigate at . UCB is actively engaging in access conversations with payers, with a focus on our patient value strategy and keeping the patient at the center of these discussions. Based on these conversations, we are progressing well toward our goal to enable access to our medicines for people who need them, in a way that is sustainable for patients, society, and UCB. Full affordability information can be found at ucb-usa.com/Sustainability/Affordability/Bimzelx-Pricing-Info and . For additional medical information, patient assistance or any other information, please call UCBCares® at 1-844-599-CARE (2273) or visit askucbcares.com. Notes to Editors: About BIMZELX® (bimekizumab-bkzx) BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.1 IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.1, 2-4 IL-17F is over-expressed in skin and highly elevated in the serum of patients with PSO, PsA, nr-axSpA, AS, and HS.1, 2-5 The approved indications for BIMZELX in the U.S. are:1 Plaque psoriasis: BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa *The recommended dosage of BIMZELX in patients is as follows: Plaque Psoriasis: Administer 320 mg by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120 kg or more, consider a dose of 320 mg every 4 weeks after Week 16. Psoriatic Arthritis: Administer 160 mg by subcutaneous injection every 4 weeks. For patients with coexisting moderate-to-severe plaque psoriasis, use the dosage and administration for plaque psoriasis. Non-Radiographic Axial Spondyloarthritis: Administer 160 mg by subcutaneous injection every 4 weeks. Ankylosing Spondylitis: Administer 160 mg by subcutaneous injection every 4 weeks. Hidradenitis Suppurativa: Administer 320 mg by subcutaneous injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14 and 16, then every 4 weeks thereafter. See full prescribing information for recommendations regarding missed doses, preparation and administration instructions. Please see Important Safety Information below and full U.S. Prescribing Information at . BIMZELX U.S. IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY INFORMATION Suicidal Ideation and Behavior BIMZELX (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment. Infections BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves. Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment. Liver Biochemical Abnormalities Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis. Inflammatory Bowel Disease Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs. Immunizations Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX. Most Common Adverse Reactions Most common (≥ 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue. Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections. Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections. Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infection. For further information, contact UCB: Investor Relations Antje Witte T +32.2.559.94.14 email [email protected] Brand Communications Nicole Herga T +1.773.960.5349 email [email protected] About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA. 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Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future. UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. References BIMZELX® (bimekizumab-bkzx) U.S. Prescribing Information. . Accessed January 2025. Glatt S, Baeten D, Baker T et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77:523–32. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate-to-severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate-to-severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021;397(10273):487-498. Rumberger BE, Boarder EL, Owens SL, et al. Transcriptomic analysis of hidradenitis suppurativa skin suggests roles for multiple inflammatory pathways in disease pathogenesis. Inflamm Res. 2020;69(10):967-973. US-BK-2401977 Date of preparation: January 2025 BIMZELX®, UCBCares®, and BIMZELX Navigate® are registered trademarks of the UCB Group of Companies. ©2025 UCB, Inc., Smyrna, GA 30080. All rights reserved. SOURCE UCB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

New trials in three new indications have been initiated with the Nanobody® sonelokimab: Phase 3 VELA-TEEN trial in adolescent hidradenitis suppurativa (HS), Phase 2 LEDA trial in palmoplantar pustulosis (PPP) and Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA)MoonLake now independently running seven trials in 2025 across large dermatology and rheumatology indications: adult HS, adolescent HS, psoriatic arthritis (PsA), PPP and axSpAPhase 2 and Phase 3 data read-outs across all target indications expected in 2025 (adult HS, and PPP) and 2026 (adolescent HS, PsA and axSpA)Data from the Phase 3 VELA-TEEN trial may be combined with the Phase 3 VELA program in adults with moderate-to-severe HS to support the first Biologics License Application (BLA) for the Nanobody® sonelokimab Zug, Switzerland, January 8, 2025 – MoonLake Immunotherapeutics (MoonLake; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced that patients have been screened in three new trials across three new indications to evaluate sonelokimab, an investigational Nanobody® designed to treat inflammatory disease. The clinical program for sonelokimab now includes patients with adolescent hidradenitis suppurativa (HS), palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA), in addition to adult patients with HS and active psoriatic arthritis (PsA). This increases the number of clinical trials led by MoonLake to ten and aligns with the plan to enroll over 3,000 patients in clinical trials with sonelokimab since the Company was founded in 2021. Evidence indicates that activation of IL-17A and IL-17F plays a crucial role in the pathophysiology of these inflammatory diseases. Sonelokimab is designed to directly target sites of inflammation by inhibiting all relevant IL-17 dimers, namely the IL-17A/A, IL-17A/F, and IL-17F/F dimers, and to penetrate difficult-to-reach inflamed tissues. The initiation of the Phase 3 VELA-TEEN trial in HS, the Phase 2 LEDA trial in PPP and the Phase 2 S-OLARIS trial in axSpA expands the portfolio of sonelokimab to large dermatology and rheumatology indications, where significant unmet needs remain. Dr. Jorge Santos da Silva, Founder and Chief Executive Officer of MoonLake Immunotherapeutics, said: “The start of three new trials across three new dermatology and rheumatology indications underscores MoonLake’s remarkable and rapid progress in independently realizing our ambitious plans. 2024 has been a year of execution, and 2025 is anticipated to mark a transformational and data-rich year as we look forward to notably reporting key Phase 3 data for HS, a market projected to reach $15bn by 2035. We are progressing towards registration and commercialization with a robust cash position. A huge thanks is due to our talented team for expanding possibilities, and of course, to all the patients and healthcare professionals for their participation in our trials.” Prof. Kristian Reich, Founder and Chief Scientific Officer at MoonLake commented: “Building upon our ongoing Phase 3 studies in HS and PsA, we are further leveraging the molecular advantages of our Nanobody®, sonelokimab, in adolescent HS, PPP, and axSpA, all diseases characterized by activation of the IL-17 and IL-17F pathway in difficult-to-reach tissues. We are pioneering a paradigm shift in innovative trial design, which has given us the agility to rapidly execute these new clinical trials.” Building upon the Phase 2 MIRA trial and ongoing Phase 3 VELA trials in adult HS, the Phase 2 ARGO trial and the ongoing Phase 3 IZAR trials in active PsA, the three new trials are: Phase 3 VELA-TEEN: the first dedicated clinical trial in adolescent patients with moderate-to-severe hidradenitis suppurativa (HS) An open-label, single-arm trial with the primary endpoint to evaluate the pharmacokinetics, safety, and tolerability of the 120mg subcutaneous (SC) dose of sonelokimab over 24 weeks in 30-40 adolescents, aged 12-17, with moderate-to-severe HS, from U.S. sites with experience in pediatric dermatology.HS is a chronic, debilitating skin condition affecting an estimated 2% of the population. It often first manifests during adolescence, and adolescent patients are particularly physically and emotionally affected by the disease. Early intervention is therefore crucial to prevent disease progression and reduce the long-term physical and emotional impact. Data from the VELA-TEEN trial may be combined with data from the Phase 3 VELA program in adults with moderate-to-severe HS to support a single Biologics License Application (BLA). Topline data for the primary and secondary endpoints, including the higher clinical response level of HiSCR75, are anticipated in 2026. Amy S. Paller, M.D, Walter J. Hamlin Professor and Chair of Dermatology and Professor of Pediatrics at Northwestern University Feinberg School of Medicine, and Principal Investigator of the trial commented: “Adolescents with HS face substantial unmet medical needs and are a critically underserved patient population. The VELA-TEEN trial marks a significant advancement in HS treatment. By prioritizing early intervention, we hope to alter the disease course, reduce tissue destruction, and prevent permanent damage.” Phase 2 LEDA: the first clinical trial in palmoplantar pustulosis (PPP) for an IL-17A and IL-17F inhibitor The trial aims to enroll approximately 30 patients across multiple sites to evaluate the 120mg SC dose of sonelokimab. The primary endpoint will be percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI).A biomarker-controlled clinical trial.The topline primary endpoint readout is expected during 2025. Mark Lebwohl, MD, Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and Chairman Emeritus, Kimberly and Eric J. Waldman Department of Dermatology commented: “Palmoplantar pustulosis is a chronic, recurrent inflammatory condition affecting the palms and soles, marked by aggressive pustule eruptions, skin destruction, and severe pain. This ongoing skin damage is debilitating, significantly impacting patients’ daily lives and activities. Despite the severity, advanced therapies remain scarce. It is exciting to see studies with innovative technologies like nanobodies to address this urgent medical need.” Phase 2 S-OLARIS: the first trial for an IL-17A and IL-17F inhibitor using an innovative design combining traditional clinical outcomes for axial spondyloarthritis (axSpA) with PET/MRI imaging An open-label trial to evaluate a 60mg SC dose of sonelokimab in approximately 25 patients with active axSpA. The primary endpoint is the change from baseline (CfB) at week 12 in the uptake of 18F-NaF in the sacroiliac joints and spine using PET in combination with MRI imaging. By combining established clinical measures with innovative PET imaging techniques and a biomarker program, the trial will for the first time measure sonelokimab's impact on deep tissue inflammation in unprecedented detail.axSpA is a chronic inflammatory condition that primarily affects the spine and sacroiliac joints, with a global prevalence ranging between 0.5% and 1.5%. Up to 40% of patients either do not respond to or cannot tolerate currently available treatments.The topline primary endpoint readout is expected in early 2026. Professor Xenofon Baraliakos, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Germany commented: “Despite advancements in axial spondyloarthritis (axSpA) treatment over the past two decades, innovation remains crucial. Many patients experience inadequate responses to current therapies, and we need to continue to push the boundaries and explore novel approaches that can address not only inflammation across several domains but potentially modify the underlying disease processes. Integrating cutting-edge imaging techniques like MRI-PET with clinical outcomes, as being used in the S-OLARIS trial, offers a promising path forward. I am excited to see such a promising innovation like nanobodies, and specifically sonelokimab, being developed for axSpA. Our goal must be to develop more effective treatments that can improve long-term outcomes, reduce disease progression, and enhance the quality of life for all axSpA patients." The Company also plans to initiate a Phase 2 trial, P-OLARIS, in patients with active PsA using an innovative design combining traditional clinical outcomes with PET/MRI imaging. - Ends - About the VELA-TEEN trialThe Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once every four weeks (Q4W) from week eight onwards. The trial aims to enroll 30-40 adolescents, aged 12-17, with moderate-to-severe hidradenitis suppurativa (HS), from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical Response Score (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the Children’s Dermatology Life Quality Index (CDLQI) and the Patients Global Assessment of Skin Pain (PGA Skin Pain). About Hidradenitis SuppurativaHS is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects an estimated 2% of the population, with three times more females affected than males. Real-world data in the US indicates that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity projected to reach $15bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity. About the S-OLARIS trialS-OLARIS is an open-label Phase 2 proof-of-concept trial aiming to investigate sonelokimab 60mg administered subcutaneously in approximately 25 patients with active axial spondylarthritis (axSpA). The primary endpoint is the change from baseline (CfB) at week 12 in the uptake of 18F-NaF in the sacroiliac joints and spine using PET in combination with MRI imaging. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also includes an exploratory peripheral blood and tissue biomarker program. About active axial spondyloarthritisAxSpA typically impacts young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age. Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported prevalence of axSpA ranges from 0.5% to 1.5%. AxSpA can be categorized by disease progression into two subtypes: non-radiographic axSpA and ankylosing spondylitis (AS), also known as radiographic axSpA, which is diagnosed based on radiographic evidence of structural changes to the sacroiliac joints. Patients with axSpA experience fatigue, persistent morning stiffness, and pain that worsens at night and can disrupt sleep. Many patients also face the burden of comorbidities such as psoriatic arthritis and psoriasis. Studies have found elevated IL-17 levels in the blood and synovial fluid of patients with axSpA, and IL-17A and IL-17F are both thought to be key contributors to pathogenesis across the spondyloarthropathies. About the LEDA TrialThe LEDA trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 120mg administered subcutaneously in adult patients with palmoplantar pustulosis (PPP). The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. About Palmoplantar PustulosisPPP is characterized by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops in adulthood, more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living. Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients. Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology. About SonelokimabSonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHH domains covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, HS and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, PPP and axSpA. For adults with HS, sonelokimab is being assessed in the Phase 3 trials, VELA-1 and VELA-2, following the successful outcome of MoonLake’s end-of-Phase 2 interactions with the FDA and as well as positive feedback from its interactions with the EMA announced in February 2024. In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR)75, which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, setting a landmark milestone. In October 2023, the full dataset from the MIRA trial at 24 weeks showed that maintenance treatment with sonelokimab led to further improvements in HiSCR75 response rates and other high threshold clinical and patient relevant outcomes. The safety profile of sonelokimab in the MIRA trial was consistent with previous trials with no new safety signals detected. A Phase 3 trial, VELA-TEEN, is also ongoing in adolescent HS, a disease that typically begins at this early stage of a patient’s life, and is also the period in which irreversible damage and inflammatory remission are most critical. For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected. Sonelokimab is also being assessed in the Phase 2 LEDA trial, which is ongoing for palmo-plantar pustulosis (PPP), a debilitating inflammatory skin condition affecting a significant number of patients. Additionally, Sonelokimab is being assessed in the ongoing Phase 2 S-OLARIS trial, for active axSpA. The trial features an innovative design complementing traditional clinical outcomes with cellular imaging techniques. Sonelokimab has also been assessed in a randomized, placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier third-party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203). About Nanobodies®Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. About MoonLake ImmunotherapeuticsMoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com. Cautionary Statement Regarding Forward Looking StatementsThis press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: plans for and timing of clinical trials, including timing of topline results of the Phase 3 VELA-TEEN clinical trial of sonelokimab in adolescent patients with HS, Phase 2 LEDA clinical trial of sonelokimab in patients with PPP, Phase 2 S-OLARIS trial in patients with axSpA, Phase 3 VELA trials in adult HS and Phase 3 IZAR trials in active PsA and initiation of Phase 2 P-OLARIS trial in patients with active PsA, the efficacy and safety of sonelokimab for the treatment of adult HS, adolescent HS, PPP, PsA and axSpA, including in comparison to existing standards or care or other competing therapies, clinical trials and research and development programs, including the combination of data from the VELA-TEEN trial in adolescents with data from the Phase 3 VELA program in adults with moderate to severe HS to support a single BLA, the anticipated timing of the results from those studies and trials and potential market opportunities for sonelokimab and MoonLake’s anticipated cash position. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake’s business in general and limited operating history, difficulty enrolling patients in clinical trials, state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates and reliance on third parties to conduct and support its preclinical studies and clinical trials and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent filings with the Securities and Exchange Commission. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. MoonLake Immunotherapeutics Media & Investors RelationsCarla Bretes, Director IR & External Communicationsir@moonlaketx.com ICR Healthcare Mary-Jane Elliott, Namrata Taak, Ashley TappTel: +44 (0) 20 3709 5700MoonLake@ICRHealthcare.com

BRUSSELS, Belgium I November 20, 2024 I UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved BIMZELX ® (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). 1 Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A). 1 “The approval of BIMZELX in moderate to severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today,” said investigator and lead author of the studies, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston, MA, U.S. “In the Phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.” Hidradenitis suppurativa is a chronic, recurring, painful and potentially debilitating inflammatory skin disease. 2,3 The main symptoms are nodules, abscesses and pus-discharging fistulas, i.e., channels leading out of the skin, typically in the armpits, groin and buttocks. 2,3 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life. 2,3 “We are working toward a world where people with hidradenitis suppurativa live without stigma, feel widely understood and are treated effectively. Today’s approval of bimekizumab-bkzx is an exciting time for the hidradenitis suppurativa community, offering a new possibility for the treatment of people in the U.S. living with moderate to severe disease,” said Brindley Brooks, Founder and Executive Director, HS Connect, U.S. The approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of bimekizumab-bkzx in the treatment of adults with moderate to severe HS. 4 Results showed that a higher proportion of patients treated with bimekizumab-bkzx vs. placebo achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials. 4 Bimekizumab-bkzx treatment also resulted in clinically meaningful improvements in the key ranked secondary endpoint, HiSCR75, vs. placebo at Week 16. 4 Clinical responses were sustained to Week 48. 4 The safety profile of bimekizumab-bkzx was consistent with safety data seen in previous trials across indications with no new safety signals. 4 Detailed results from BE HEARD I and BE HEARD II have been published in The Lancet . 4 “We are thrilled that with this milestone BIMZELX is now FDA-approved for the treatment of adults with moderate to severe hidradenitis suppurativa, a chronic and painful disease affecting approximately one in 100 people. This is the fifth patient population who may benefit from BIMZELX in the U.S., representing a significant step forward in our mission to alleviate the global burden of immune-mediated inflammatory diseases,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact and Chief Commercial Officer, UCB. “This progress underscores our commitment to addressing unmet needs in hidradenitis suppurativa and other immunological conditions, delivering innovative medicines and raising standards of care.” This FDA approval of bimekizumab-bkzx for the treatment of adults with moderate to severe hidradenitis suppurativa follows its recent approvals for the treatment of adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation and adults with active ankylosing spondylitis. 1 Bimekizumab-bkzx was first approved in the U.S. in October 2023, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 1 Notes to Editors: About BE HEARD I and BE HEARD II BE HEARD I and BE HEARD II are randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 3 studies designed to evaluate the efficacy and safety of bimekizumab-bkzx in adults with moderate to severe hidradenitis suppurativa (HS). 4 The two studies had a combined enrolment of 1,014 participants with a diagnosis of moderate to severe HS. 4 The primary endpoint in both studies was HiSCR50 at Week 16. 4 Secondary endpoints included HiSCR75 and HS-specific skin pain response at Week 16. 1,4 HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.4 Detailed results from these studies are published in The Lance t. 4 About BIMZELX® (bimekizumab-bkzx) in the U.S. Bimekizumab-bkzx is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex. 1 Please see Important Safety Information below and full U.S. Prescribing Information at http://www.ucb-usa.com/Innovation/Products/BIMZELX . BIMZELX U.S. IMPORTANT SAFETY INFORMATION Suicidal Ideation and Behavior BIMZELX ® (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B).  A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established.  Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment. Infections BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated.  In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX.  Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves. Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment. Liver Biochemical Abnormalities Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase and bilirubin at baseline, periodically during treatment with BIMZELX and according to routine patient management.  If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded.  Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin.  Avoid use of BIMZELX in patients with acute liver disease or cirrhosis. Inflammatory Bowel Disease Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX.  Avoid use of BIMZELX in patients with active IBD.  During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs. Immunizations Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX. Most Common Adverse Reactions Most common adverse reactions (≥ 1%) in plaque psoriasis and hidradentitis suppurativa include  upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue. Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections. Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections. Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infections. Please see Important Safety Information below and full U.S. Prescribing Information at www.UCB-USA.com/Innovation/Products/BIMZELX . About BIMZELX ® ▼(bimekizumab) in the European Union (EU)/European Economic Area (EEA) The approved indications for bimekizumab▼ in the EU are: 5 The label information may differ in other countries where approved. Please check local Prescribing Information. BIMZELX ® ▼(bimekizumab) EU/EEA Important Safety Information The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS, respectively). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, vulvovaginal mycotic infection (including vulvovaginal candidiasis), headache, rash, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab. Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis). Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB. Patients receiving bimekizumab should be monitored for signs and symptoms of active TB. Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated. Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated. Live vaccines should not be given in patients treated with bimekizumab. Please consult the Summary of Product Characteristics in relation to other side effects, full safety and Prescribing Information. European SmPC date of revision: August 2024. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf . Last accessed: November 2024. ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. References SOURCE: UCB