Bimekizumab

MoonLake Immunotherapeutics on Saturday announced a mixed bag of results from two pivotal studies investigating its trispecific IL-17A/F Nanobody sonelokimab in hidradenitis suppurativa (HS), with one trial hitting its mark, and the other falling short owing to a placebo response above estimates.The Swiss biotech reported interim week 16 results from its Phase III VELA-1 and VELA-2 trials, which together enrolled 838 patients with moderate-to-severe HS, comparing a single 120-mg subcutaneous dose of sonelokimab to placebo. Results showed VELA-1 met its primary endpoint, demonstrating 34.8% of patients on sonelokimab achieved HiSCR75 — a 75% reduction in inflammatory lesions — compared with 17.5% for placebo. Meanwhile, VELA-2 failed to reach statistical significance as per the pre-specified composite analysis strategy, despite showing a 35.9% response rate on HiSCR75 versus 25.6% for placebo. Additionally, sonelokimab met all key secondary endpoints in both studies, including HiSCR50, IHS4-55 and several patient-reported outcomes compared with placebo on the composite strategy."The higher-than-expected placebo response rate in VELA-2 is disappointing but we are encouraged by the consistent performance of sonelokimab arms across all endpoints in both studies," said Kristian Reich, chief scientific officer at MoonLake.MoonLake, however, noted that upon analysis by an alternative pre-specified treatment policy approach, the sonelokimab arms in both studies achieved statistically significant gains across all primary and key secondary endpoints against placebo.Safety-wise, sonelokimab's profile was consistent with previous studies, with no new signals recorded for events of interest associated with IL-17A and F therapies, including suicidal ideation, hepatic events, inflammatory bowel disease, and major adverse cardiovascular events. Nasopharyngitis, headache, and upper respiratory tract infections were the common adverse events, with oral candidiasis occurring at a much higher frequency of 7.3% in sonelokimab recipients compared with placebo’s 0.4%.Eyeing 2027 launchMoonLake is slated to discuss the interim findings with regulators to chart a path forward for filings, while awaiting the 52-week data expected in the second quarter of next year. Armed with a $500 million financing package from Hercules Capital earlier this year, the biotech is aiming for a 2027 launch of the Nanobody in inflammatory conditions. If approved for HS, the trispecific antibody would need to take on UCB’s IL-17A/F inhibitor Bimzelx (bimekizumab), which gained FDA clearance for the same indication last year. Jorge Santos da Silva, chief executive of Moonlake, earlier told FirstWord that sonelokimab’s smaller size conferred it a key advantage over traditional antibodies, enabling faster and deeper tissue penetration. For more, see – ViewPoints: Why MoonLake's CEO sees sonelokimab eclipsing rivals in HS.Intron Health analyst Naresh Chouhan earlier this month said while “the market is fretting about the potential for sonelokimab to become a challenger to Bimzelx,” the perceived threats to UCB might be overstated.Besides the lead indications HS and psoriatic arthritis, MoonLake continues exploring sonelokimab in palmo-plantar pustulosis and axial spondyloarthritis.

Symptom relief sustained to three years: Improvements in the stringent endpoints HiSCR75, HiSCR90, and HiSCR100 at one year were sustained to three years in 81.2%, 64.3%, and 50.1% of patients, respectively* Resolution of inflammatory lesions: Of patients who achieved IHS4-100 (European clinical metric to assess the severity of HS1) at year one, 64.3% achieved and maintained this complete resolution of inflammatory lesions through to two years* Impact of earlier treatment: Across the high-efficacy IHS4 threshold, patients treated earlier in their moderate-to-severe HS with BIMZELX® (bimekizumab-bkzx) had improved outcomes at two years* Dual inhibition: BIMZELX® (bimekizumab-bkzx) is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A)2 ATLANTA, Sept. 17, 2025 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced three-year data from the BE HEARD trials for BIMZELX® (bimekizumab-bkzx) in adults with moderate-to-severe hidradenitis suppurativa (HS). BIMZELX, the first and only approved medicine to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),2 continued to be generally well tolerated, and demonstrated sustained symptom relief.3-9 "A crucial goal for treating people with hidradenitis suppurativa is achieving and maintaining long-term disease control at the most stringent levels," said John Ingram, Professor of Dermatology, Cardiff University. "These data for bimekizumab – including HiSCR100 and IHS4-100 – showed symptom relief can be maintained long-term." Among patients with HS, improvements in HiSCR50/75/90/100 seen at one year were sustained to three years in 90.2% (331/367), 81.2% (298/367), 64.3% (236/367), and 50.1% (184/367) of patients, respectively.3* Improvements in quality of life, as measured by DLQI 0/1, seen at year one in 27.4% (151/551) of patients were sustained to three years, with 38.1% (137/360) of patients reporting no effect of skin disease on their quality of life.3* Patients who achieved IHS4-55/75/90/100 at Week 48 maintained this response to two years in 90.8% (315/347), 85.1% (235/276), 71.2% (136/191) and 64.3% (74/115) of cases, respectively.4* Patients with shorter disease duration since HS diagnosis had better outcomes than those with longer disease duration, particularly at higher efficacy thresholds, emphasizing the potential impact of earlier treatment with BIMZELX upon diagnosis of moderate-to-severe HS.5* At Week 96, proportions of patients in the lowest disease duration quartile (<2.38 years [n=115]) achieving IHS4-55/75/90/100 were 88.7% (n=102), 73.9% (n=85), 59.1% (n=68), and 46.1% (n=53), respectively.5* Similarly, IHS4-55/75/90/100 responses in the highest disease duration quartile (≥10.74 years [n=101]) at Week 96 were 77.2% (n=78), 62.4% (n=63), 39.6% (n=40) and 22.8% (n=23), respectively.5* Over two years, at the patient level, BIMZELX treatment reduced the number of draining tunnels in the majority of individuals.6* In addition, over two years of treatment with BIMZELX, a greater reduction in skin pain severity translated into an improvement in health-related quality of life for people living with HS.7* "The three-year data on bimekizumab presented at EADV demonstrated deep and sustained responses across stringent efficacy endpoints, as well as long-term improvements in health-related quality of life for people living with hidradenitis suppurativa," said Donatello Crocetta, Head of Medical and Chief Medical Officer, UCB. "Long-term efficacy and safety data are vital for advancing understanding of chronic inflammatory conditions like hidradenitis suppurativa, and these findings underscore UCB's commitment to advancing science-led insights and providing transformative treatment options to improve outcomes for patients." Treatment with BIMZELX was generally well tolerated, with no new safety signals observed up to three years.3* The safety profile up to three years was consistent with years one and two.3* UCB's data on BIMZELX in HS will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France, September 17-20. The abstracts are part of the 19 other presentations from UCB across BIMZELX in psoriasis, psoriatic arthritis, axial spondyloarthritis, as well as the abstract for the investigational therapy galvokimig in atopic dermatitis.† *OC: Data are reported as observed case (OC). The data reported are from an open-label study. Patients completing the 48-week BE HEARD I & II studies could enroll in BE HEARD EXT and receive open-label BIMZELX (BKZ) 320 mg every 2 weeks (Q2W) or Q4W based on HiSCR90 response averaged from Weeks 36, 40, and 44. Data are reported for patients randomized to BKZ from baseline in BE HEARD I & II who entered BE HEARD EXT (BKZ Total group, n=556) at Week 48. Only patients who entered the third year are included.3-6 †Galvokimig is currently under clinical investigation and is not approved by any regulatory authority worldwide. Notes to Editors: HiSCR50/HiSCR75/HiSCR90/HiSCR100: These are defined as at least a 50%/75%/90%/100% reduction in the total abscess and inflammatory nodule count from baseline with no increase from baseline in abscess or draining tunnel count.10,14 IHS4‑55/75/90/100: IHS4 is the clinician-rated International HS Severity Score System (IHS4), which evaluates the number of inflammatory nodules/abscesses/draining tunnels. IHS4‑55/75/90/100 is defined as at least a 55%/75%/90%/100% improvement from baseline in a patient's IHS4 total score. IHS4-100 equates to complete resolution of inflammatory lesions.5 Draining tunnels: These are painful, pus-discharging tunnels under the skin resulting from long-term inflammation, frequently leading to scarring.11-12 DLQI 0/1: Dermatology Life Quality Index (DLQI) is a patient-reported questionnaire consisting of 10 questions concerning symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.13 Each question is scored from 0 to 3 and the scores summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment).13 All questions relate "to the last week." The DLQI was designed to be used in adults over the age of 18 years.13 DLQI 0/1 denotes patients who achieved an overall score of 0 or 1 in the questionnaire, and denotes no effect at all on a patient's quality of life.13 Results included patients receiving both Q2W and Q4W after Week 48. All patients who continued in the trial after Week 48 were subsequently switched to Q4W by the end of year three. For safety outcomes, data are reported for patients who received one or more dose of BKZ across BE HEARD I & II and BE HEARD EXT (total of three years). The FDA approved dose of BIMZELX for adult patients with moderate-to-severe hidradenitis suppurativa is 320mg Q2W to Week 16, followed by Q4W. The most common treatment emergent adverse events (TEAEs) rates were hidradenitis (19.6/100 patient years [PY]), coronavirus infection (14.1/100 PY), and oral candidiasis (9.3/100 PY).3* About hidradenitis suppurativa Hidradenitis suppurativa (HS) is a chronic, painful, and potentially debilitating inflammatory skin disease that is associated with systemic manifestations.11-12 The main symptoms are nodules, abscesses, and pus‑discharging draining tunnels (or sinus tracts leading out of the skin), which typically occur in the armpits, groin, and buttocks.11-12 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.11-12 HS develops in early adulthood and affects approximately one percent of the population in most studied countries.11-12 About BE HEARD trials The efficacy and safety profiles of BIMZELX were evaluated in adult patients with moderate-to-severe hidradenitis suppurativa (HS) in two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (BE HEARD I and BE HEARD II).14 The two studies had a combined enrollment of 1,014 participants.14 In each study, patients were randomized 2:2:2:1 (initial [16 weeks]/maintenance [32 weeks]) to BIMZELX 320 mg every two weeks, four weeks, or a combination (BKZ Q2W/Q2W, BKZ Q2W/Q4W, BKZ Q4W/Q4W or placebo/BKZ Q2W).14 Patients who completed Week 48 could enroll in the open-label extension.15 Of 1,014 total patients, 556 patients randomized at baseline to BIMZELX in BE HEARD I and II completed Week 48 and entered the open-label extension study; 446 patients in the open-label extension study completed Week 96,11 and 367 completed to Week 148.3 For details about BE HEARD EXT: . 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.2 IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.2,16-18 IL-17F is over-expressed in skin and highly elevated in the serum of patients with psoriasis (PSO), psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis (AS), and hidradenitis suppurativa (HS).2,16-19 The approved indications for BIMZELX in the U.S. are:2 Plaque psoriasis: BIMZELX is indicated 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 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. Please see full U.S. Prescribing Information at . 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 €6.1 billion in 2024. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on X: @UCBUSA. 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Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB. UCB expressly disclaims any obligation to update any forward-looking statements in this document, 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. References Zouboulis CC, et al., "Development and validation of the International Hidradenitis Suppurativa Severity Score System (IHS4), a novel dynamic scoring system to assess HS severity," British Journal of Dermatology, vol. 177, no. 5, pp. 1401–1409, Nov. 2017. BIMZELX® (bimekizumab-bkzx) U.S. Prescribing Information. . Ingram J. 2025. EADV. Bimekizumab efficacy and safety through 3 years in patients with hidradenitis suppurativa: Results from the phase 3 BE HEARD I&II trials and their open-label extension BE HEARD EXT. Oral D1T01.2E. Ingram J, Lev-Tov H, Kyrgidis A, et al. Bimekizumab maintenance of response over 2 years: Data from BE HEARD EXT. [poster]. EADV 2025. #P2920. Tzellos T, Sayed C, Zouboulis C, et al. Bimekizumab efficacy on IHS4 response levels and draining tunnels by HS disease duration over 2 years: Data from BE HEARD EXT. [poster]. EADV 2025. #Oral FC06. Garg A, Kimball A, Guillem P, et al. [poster]. Bimekizumab impact on hidradenitis suppurativa lesions over 2 years: Data from BE HEARD EXT. [poster]. EADV 2025. #P2839. Kirby B, Daveluy S, Reguiai Z, et al. Bimekizumab influences the association between HS skin pain severity and health-related quality of life over 2 years: Data from BE HEARD EXT. [poster]. EADV 2025. #P2837. van Straalen R, Gottlieb A, Pinter A, et al. Bimekizumab effect on health-related quality of life and symptoms over 2 years: Data from BE HEARD EXT. [poster]. EADV 2025. #P3291. Ingram J, Naik H, Zouboulis C, et al. Bimekizumab safety and tolerability in patients with moderate to severe hidradenitis suppurativa: 2-year results from BE HEARD EXT. [poster]. EADV 2025. #P2652. Garg A, Zema C, Ciaravino V, et al. Validation of the Hidradenitis Suppurativa Investigator Global Assessment: A Novel Hidradenitis Suppurativa–Specific Investigator Global Assessment for Use in Interventional Trials. JAMA Dermatol. 2023;159(6):606–612. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–64. Lewis V and Finlay A. 10 Years Experience of the Dermatology Life Quality Index (DLQI). J Investig Dermatol Symp Proc. 2004;9(2):169–80. Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48 week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504–19. Zouboulis CC, Garg A, Sayed CJ, et al. Bimekizumab efficacy and safety through 2 years in patients with hidradenitis suppurativa: Results from the phase 3 BE HEARD I&II trials and open-label extension BE HEARD EXT [abstract]. Skin. 2024,8(6):s473. EADV. 7925. 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-2501215 Date of preparation: September 2025 BIMZELX® is a registered trademark 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