A Multi-center, Randomized, Double-blind, Active Controlled Study to Assess Efficacy, Safety and Tolerability of the Anti-IL13 Monoclonal Antibody QAX576 in the Treatment of Perianal Fistulas in Patients Suffering From Crohn's Disease

This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.

Start Date01 Jun 2011

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT01316601

/ CompletedPhase 2IIT

A Study to Assess Efficacy, Safety and Tolerability of the Anti-IL-13 Monoclonal Antibody QAX576 in the Treatment of Perinanal Fistulas in Patients Suffering From Crohn's Disease

Test safety and efficacy and of a novel IL-13 AB in the treatment of perianal fistulas
Trial with medicinal product

Start Date01 Jan 2011

Sponsor / Collaborator

University of Zurich

[+1]

NCT01266135

/ TerminatedPhase 2

Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPF

This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.

Start Date01 Dec 2010

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with Dectrekumab

100 Translational Medicine associated with Dectrekumab

100 Patents (Medical) associated with Dectrekumab

Literatures (Medical) associated with Dectrekumab

01 Jan 2025·Annals of Dermatology

Effectiveness of Switching From Upadacitinib to Tralokinumab in Patients With Moderate-to-Severe Atopic Dermatitis: A Real-World Clinical Practice

Article

Author: Hagino, Teppei ; Fujimoto, Eita ; Saeki, Hidehisa ; Kanda, Naoko

BACKGROUND:

Atopic dermatitis (AD) is a chronic eczematous disorder characterized by intense itchiness. Systemic therapies for AD include Janus kinase (JAK) inhibitors and various biological agents. The effects of transitioning from the JAK1 inhibitor, upadacitinib, to the anti-interleukin 13 antibody, tralokinumab, remain unclear.

OBJECTIVE:

This study evaluated the transition from 15 mg of upadacitinib to tralokinumab in patients with moderate-to-severe AD.

METHODS:

This analysis included 20 patients who switched from 15 mg of upadacitinib to tralokinumab due to an inadequate response or adverse events (AEs). We assessed the total and regional eczema area and severity index (EASI), which included assessments of the head and neck, trunk, and upper and lower limbs, along with erythema, edema/papulation, excoriation, lichenification, and the peak pruritus numerical-rating scale (PP-NRS), initially (start of 15 mg of upadacitinib), at the transition point (week 0), and during follow-up at weeks 4 and 12.

RESULTS:

The EASI, EASI of the four anatomical regions, and EASI of the four clinical manifestations significantly declined from baseline at weeks 4 and 12, with no substantial reductions from week 0. The PP-NRS score notably decreased from baseline at week 4. Achieving EASI of 50 and 75 improved post-switching.

CONCLUSION:

Transitioning to tralokinumab substantially alleviated rash in patients with AD who experienced suboptimal responses or AEs to 15 mg of upadacitinib.

01 Dec 2024·Contemporary Clinical Trials

Design of a phase 3, randomized, double-blind, placebo-controlled, 48-week study to evaluate the efficacy and safety of cendakimab in adult and adolescent patients with eosinophilic esophagitis

Article

Author: Patel, Vrunda ; de Oliveira, Claudia H M C ; Hirano, Ikuo ; Charriez, Christina M. ; de Oliveira, Claudia H.M.C. ; Dellon, Evan S ; Oh, Young S. ; Charriez, Christina M ; Zhang, Sandra ; Schoepfer, Alain ; Dellon, Evan S. ; Oh, Young S

BACKGROUND:

Eosinophilic esophagitis (EoE) is a chronic, immune-mediated inflammatory condition that interferes with normal food ingestion, negatively impacting quality of life (QoL). Treatment options include proton pump inhibitors, corticosteroids, biologics, or dietary elimination; however, ∼1/3 of patients remain insufficiently controlled. The pathogenesis of EoE involves interleukin-13 (IL-13); therefore, targeted IL-13 inhibition may be beneficial. In a phase 2 study, cendakimab, a recombinant, humanized anti-IL-13 monoclonal antibody, significantly reduced mean esophageal eosinophil counts and improved other inflammatory parameters in patients with EoE. These findings prompted further investigation of the efficacy and safety of cendakimab in adults and adolescents with EoE in a phase 3 registrational study (NCT04753697), the design of which is presented here.

METHODS:

This multicenter, multinational, randomized, double-blind, placebo-controlled, 48-week, treat-through study plans to enroll 399 adults and adolescents. Randomized patients (1:1:1) will receive subcutaneous administration of 1) cendakimab 360 mg once weekly (QW) for 48 weeks, 2) cendakimab 360 mg QW for 24 weeks followed by cendakimab 360 mg every other week (with matching placebo on alternative weeks to maintain the blind) for 24 weeks, or 3) placebo QW for 48 weeks. Co-primary endpoints are mean change from baseline in dysphagia days and proportion of patients with eosinophil histologic response, defined as peak esophageal eosinophil count ≤6 per high-power field, at 24 weeks. Secondary and exploratory endpoints will address endoscopic and histologic features, QoL, safety, and pharmacokinetic assessments.

CONCLUSION:

This phase 3 pivotal study will determine whether cendakimab provides an effective, safe, targeted treatment for patients with EoE.

01 Oct 2024·EUROPEAN JOURNAL OF DERMATOLOGY

Effectiveness and safety of tralokinumab treatment for moderate-to-severe atopic dermatitis in real-world clinical practice in Japan

Article

Author: Hagino, Teppei ; Onda, Marina ; Saeki, Hidehisa ; Fujimoto, Eita ; Kanda, Naoko

Tralokinumab is a human monoclonal anti-interleukin-13 antibody approved as systemic treatment for atopic dermatitis (AD). We aimed to evaluate effectiveness and safety of tralokinumab for AD in real-world clinical practice. We analysed Japanese patients with AD from October 2023 to March 2024. All patients were subcutaneously injected with tralokinumab, 300 mg every two weeks, after an initial injection of 600 mg and twice-daily topical corticosteroids of moderate to strongest class until week 12. In this study, 103 patients were analysed. At week 4 and 12, 54.7 % and 83.0 % achieved eczema area and severity index (EASI) 50, 22.7 % and 38.3 % achieved EASI 75, 90 8.0 % and 23.4 % achieved EASI, 32.0 % and 55.3 % achieved EASI ≤7, and 1.3 % and 14.0 % achieved Investigator's Global Assessment 0/1, respectively. At week 4 and 12, 52.9 % and 51.2 % achieved Peak Pruritus-Numerical Rating Scale (PP-NRS) 4, 16.5 % and 15.6 % achieved PP-NRS ≤1, and 57.9 % and 75.0 % achieved Atopic Dermatitis Control Tool 7, respectively. Serum levels of immunoglobulin E, thymus and activation-regulated chemokine, and lactate dehydrogenase significantly decreased at week 12 compared to baseline. Treatment-emergent adverse events occurred in 14.8 % of patients, which were mild and manageable. Notably, conjunctivitis occurred in 2.9 % of patients but was mild and resolved spontaneously. Tralokinumab for patients with AD was well-tolerated and provided favourable therapeutic effects in real-world clinical practice.

News (Medical) associated with Dectrekumab

07 Mar 2025

·www.prnewswire.com

Lilly's EBGLYSS® (lebrikizumab-lbkz) single monthly maintenance injection achieved completely clear skin at three years in half of patients with moderate-to-severe atopic dermatitis

Among EBGLYSS Week 16 responders from the monotherapy trials, 50% achieved highest bar of complete skin clearance (EASI 100 or IGA 0) and 87% achieved almost-clear skin (EASI 90) at three years with single monthly maintenance injection Additional studies demonstrated EBGLYSS significantly improved itch, skin pain, and sleep loss due to itch for a range of patients with atopic dermatitis EBGLYSS was approved in the U.S. in September 2024 as a first-line monotherapy biologic treatment option following topical prescription therapies INDIANAPOLIS, March 7, 2025 /PRNewswire/ -- New results show Eli Lilly and Company's (NYSE: LLY) EBGLYSS achieved deep and sustained response for patients with moderate-to-severe atopic dermatitis (eczema) at three years. These findings from the ADjoin long-term extension study will be presented at the American Academy of Dermatology (AAD) Annual Meeting, taking place March 7-11 in Orlando.1 EBGLYSS is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity.2,3,4 The cytokine IL-13 is a primary cytokine in atopic dermatitis, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.5,6 Three-year depth of response data being presented are part of ADjoin, the long-term extension study of the EBGLYSS trials, and include participants who responded to EBGLYSS treatment at Week 16 from ADvocate 1 and ADvocate 2 monotherapy trials. Patients received a maintenance dose of 250 mg EBGLYSS either every two weeks or once monthly (every four weeks) and were assessed for depth of response using IGA 0, EASI 90 and EASI 100.*1 The approved maintenance dose of EBGLYSS is 250 mg once monthly, after taking EBGLYSS every two weeks for the four-month initial dosing phase (or later once achieving adequate clinical response).7 Of the patients who responded to treatment at Week 16 and were receiving once-monthly maintenance dosing, 50% of patients achieved complete skin clearance (EASI 100 or IGA 0) at three years. Additionally, 87% achieved or maintained almost-clear skin (EASI 90) at three years.1 Over 83% of Week 16 responders taking EBGLYSS did not require the use of concomitant therapies such as topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) for the duration of the ADjoin study.1 "Healthcare providers are constantly searching for ways to help patients achieve deep, sustainable improvement in the signs and symptoms of their atopic dermatitis," said Raj Chovatiya, M.D., Ph.D., MSCI, Clinical Associate Professor, Rosalind Franklin University Chicago Medical School, Founder and Director of the Center for Medical Dermatology + Immunology Research. "These three-year data show that raising the bar in atopic dermatitis treatment to long-term total skin clearance was an achievable treatment goal for at least half of EBGLYSS Week 16 responders, reinforcing its efficacy as a first-line biologic treatment for people with moderate-to-severe atopic dermatitis uncontrolled by topicals." Additional study assessments conducted in patients with skin of color (ADmirable) and patients who were previously treated with dupilumab (ADapt) will also be presented at the meeting. Improvements of itch, skin pain (discomfort and soreness) and itch interference on sleep were measured using clinically meaningful thresholds for the validated patient-reported outcomes.8,9 In ADmirable, a first-of-its-kind EBGLYSS study specifically designed for people with skin of color and moderate-to-severe atopic dermatitis, nearly 60% of patients achieved significant improvement in itch (Pruritus NRS ≥4-point improvement from baseline) and skin pain (≥4-point improvement from baseline) at Week 16 (58% and 59% respectively). Over 30% of patients saw a reduction in sleep loss due to itch (≥2-point improvement from baseline in Sleep-Loss Scale) at Week 16.8 In ADapt, a study of patients taking EBGLYSS who were previously treated with dupilumab, 75% achieved significant improvement in skin pain (≥4-point improvement from baseline) and 62% achieved significant improvement in itch (Pruritus NRS ≥4-point improvement from baseline) at Week 24. Forty-two percent of patients saw a reduction in sleep loss due to itch (≥2-point improvement in Sleep-Loss Scale) at Week 24.9 The reported endpoints for all studies were as observed.1,8,9 The safety profile in these studies was consistent with previous EBGLYSS Phase 3 studies in patients with moderate-to-severe atopic dermatitis, regardless of dose frequency, and no new safety signals were observed. The majority of adverse events were mild or moderate and did not lead to discontinuation. Reported treatment-related side effects in the studies were conjunctivitis and injection-site reactions. "We hear from patients with moderate-to-severe atopic dermatitis that they struggle with recurring and unpredictable flares and are looking for treatment options that can provide long-term disease control," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "EBGLYSS is the only first-line biologic treatment option for patients with disease uncontrolled by topicals to report completely clear skin at three years with a once-monthly maintenance dose. The additional assessments presented at AAD demonstrate significant improvements in disruptive symptoms, such as itch, across a range of patient groups." Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe. Lilly's partner Almirall has licensed the rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including atopic dermatitis, in Europe. *EASI=Eczema Area and Severity Index, EASI-90=90% reduction in EASI from baseline, EASI-100=100% reduction in EASI from baseline; IGA=Investigator's Global Assessment 0 or 1 ("clear" or "almost clear"). About ADjoin ADjoin (NCT04392154) evaluated the long-term safety and efficacy of EBGLYSS treatment in patients with moderate-to-severe atopic dermatitis for up to 100 weeks (up to 152 weeks of continuous treatment with the parent studies). Patients taking EBGLYSS who completed any of the parent studies (ADvocate 1 and 2 monotherapy trials, ADhere, ADore, ADopt-VA) were able to enroll in ADjoin. The ADhere parent study included patients taking topical corticosteroids with EBGLYSS as a combination therapy. Patients could also enroll directly into ADjoin without participating in a parent study. Patients in this analysis of the long-term extension trial received a maintenance dose of either EBGLYSS 250 mg every two weeks or once monthly.1 About ADmirable ADmirable (NCT05372419) is a Phase 3b, open-label, 24-week study evaluating the safety and efficacy of EBGLYSS in adults and adolescents (12 to less than 18 years of age and weighing ≥40 kg) with skin of color and moderate-to-severe atopic dermatitis and defining innovative objective measures of pigment, and post-inflammatory hyper and hypopigmentation. Patients enrolled in the ADmirable study received a starting dose of EBGLYSS 500 mg subcutaneously initially and at two weeks followed by 250 mg every two weeks until Week 16. IGA 0,1 or EASI-75 responders at Week 16 received 250 mg once monthly and non-responders continued on 250 mg every two weeks until Week 24. Patients were allowed to stay on low- and mid-potency topical corticosteroids.8 About ADapt ADapt (NCT05369403), is an open-label, Phase 3b, 24-week study that evaluated the efficacy and safety of EBGLYSS in adults and adolescents (12 to less than 18 years of age and weighing ≥40 kg) with moderate-to-severe atopic dermatitis who were previously treated with dupilumab. After discontinuing dupilumab, patients were treated with EBGLYSS and received a starting dose of 500 mg subcutaneously initially and at two weeks followed by 250 mg every two weeks until Week 16. IGA 0,1 or EASI-75 responders at Week 16 received 250 mg once monthly and non-responders continued on 250 mg every two weeks until Week 24. Patients were allowed to stay on low- and mid-potency topical corticosteroids.9 INDICATION AND SAFETY SUMMARY EBGLYSS™ (EHB-glihs) is an injectable medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. EBGLYSS can be used with or without topical corticosteroids. It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg). Warnings - Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients. Before using Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you: Have a parasitic (helminth) infection. Are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with EBGLYSS. Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy. Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Possible side effects EBGLYSS can cause serious side effects, including: Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing swelling of the face, lips, mouth, tongue or throat hives itching fainting, dizziness, feeling lightheaded skin rash cramps in your stomach area (abdomen) Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. The most common side effects of EBGLYSS include: eye and eyelid inflammation, including redness, swelling, and itching injection site reactions shingles (herpes zoster) These are not all of the possible side effects of EBGLYSS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or . How to take See the detailed "Instructions for Use" that comes with EBGLYSS for information about how to prepare and inject EBGLYSS and how to properly store and throw away (dispose of) used EBGLYSS prefilled pens and prefilled syringes. Use EBGLYSS exactly as prescribed by your healthcare provider. EBGLYSS is given as an injection under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give the injections of EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider. In children 12 years of age and older, EBGLYSS should be given by a caregiver. If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time. Learn more EBGLYSS is a prescription medicine available as a 250 mg/2 mL injection prefilled pen or prefilled syringe. For more information, call 1-800-545-5979 or go to ebglyss.lilly.com This summary provides basic information about EBGLYSS but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about EBGLYSS and how to take it. Your doctor is the best person to help you decide if EBGLYSS is right for you. LK CON BS AD APP EBGLYSS®, its delivery device base, and Lilly Support Services™ are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. About EBGLYSS EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate.5,6,7 EBGLYSS binds to the IL-13 cytokine at an area that overlaps with the binding site of the IL-4Rα subunit of the IL-13Rα1/IL-4Rα heterodimer, preventing formation of this receptor complex and inhibiting IL-13 signaling. IL-13 is implicated as a primary cytokine tied to the pathophysiology of eczema, driving the type-2 inflammatory loop in the skin, and EBGLYSS selectively targets IL-13.7 The EBGLYSS Phase 3 program consists of five key global studies evaluating over 1,300 patients, including two monotherapy studies (ADvocate 1 and 2), a combination study with topical corticosteroids (ADhere), as well as long-term extension (ADjoin) and adolescent open label (ADore) studies. Further data results from ADmirable are expected to be shared in 2025. EBGLYSS was approved in the U.S. by the Food and Drug Administration (FDA) in 2024 as the only first-line monotherapy biologic treatment with once-monthly maintenance dosing for adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis that is not well controlled with topical prescription therapies.7 EBGLYSS 250 mg/2 mL injection is dosed as a single monthly maintenance injection following the initial phase of treatment. The recommended initial starting dose of EBGLYSS is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later when adequate clinical response is achieved; after this, maintenance dosing is a single monthly injection (250 mg every four weeks).7 Lilly is committed to serving patients living with moderate-to-severe atopic dermatitis and is working to enable broad first-line biologic access to EBGLYSS following topical prescription therapy through commercial insurance and as of March 1, Lilly gained coverage with two national pharmacy benefit managers. We are also pursuing similarly broad Medicaid and Medicare coverage as part of Lilly's health equity and affordability initiative. Through Lilly Support Services™, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about EBGLYSS (lebrikizumab-lbkz) as a treatment for patients with moderate-to severe atopic dermatitis and the timeline for future readouts, presentations, and other milestones relating to EBGLYSS and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with the results to date or that EBGLYSS will receive additional regulatory approvals, or that it will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. 1 Simpson E, et al. Raising the Bar of Efficacy in Atopic Dermatitis: Lebrikizumab Maintains Depth of Response Over 3 Years in Week 16 Responders. American Academy of Dermatology Annual Meeting. March 7, 2025. 2 Simpson EL, et al. Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE). J Am Acad Dermatol. 2018;78(5):863-871.e11. doi:10.1016/j.jaad.2018.01.017 3 Okragly A, et al. Binding, Neutralization and Internalization of the Interleukin-13 Antibody, Lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535-1547. doi:10.1007/s13555-023-00947-7 4 Ultsch M, et al. Structural basis of signaling blockade by anti-IL-13 antibody Lebrikizumab. J Mol Biol. 2013;425(8):1330-1339. doi:10.10116/j.jmb.2013.01.024 5 Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54–62. doi:10.1111/all.13954 6 Tsoi LC, et al. Atopic Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity Compared to Psoriasis. J Invest Dermatol. 2019;139(7):1480-1489. doi:10.1016/j.jid.2018.12.018 7 EBGLYSS. Prescribing Information. Lilly USA, LLC. 8 Alexis A, et al. Lebrikizumab Improves Itch, Skin Pain, and the Interference of Itch on Sleep in Adult and Adolescent Patients with Moderate-to-Severe Atopic Dermatitis and Skin of Color: 16-Week Results from the ADmirable Study. American Academy of Dermatology Annual Meeting. March 7, 2025. 9 Yosipovitch G, et al. Lebrikizumab Improves Itch, Itch Interference on Sleep and Skin Pain in Patients with Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab. American Academy of Dermatology Annual Meeting. March 7, 2025. SOURCE Eli Lilly and Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug Approval

03 Apr 2024

·synapse.patsnap.com

Idiopathic Pulmonary Fibrosis: Current Clinical Research Status Targeting GPCR

In September last year, the South Korean biopharmaceutical company GPCR Therapeutics published a research paper in "Cell Communication and Signaling" about the direct interaction between two different GPCRs (CXCR4 and LPA1). Through various in vitro experiments, the company discovered that the efficacy of LPA1 inhibitors could be enhanced to its maximum potential by inhibiting CXCR4, thereby providing scientific evidence that the combination of CXCR4-LPA1 inhibitors might be a necessary condition for comprehensive antifibrotic activity. Based on this discovery, GPCR Therapeutics filed a provisional patent application for a combined therapeutic method involving CXCR4-LPA1 inhibitors. GPCR Therapeutics will collaborate with Bridge Biotherapeutics to jointly develop and commercialize this combined therapy. Bridge Biotherapeutics is conducting a phase 2a multinational clinical trial for the autonomic sympatho-inhibitor BBT-877, intended for the treatment of idiopathic pulmonary fibrosis (IPF), and is accelerating the development of its proprietary IPF product pipeline. About Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF) is a progressive chronic lung disease that leads to scarring (fibrosis) of the lungs, resulting in stiffening and loss of elasticity of the lung tissues, making breathing increasingly difficult. The efficiency of oxygen transfer in the lungs decreases, thus the process of oxygen passing from the alveoli to the blood during inhalation is compromised in IPF patients. The lung damage caused by IPF is irreversible, and currently, there are no treatment methods available that can stop or reverse the formation of scarring. The prognosis of Idiopathic Pulmonary Fibrosis is generally poor and the progression of the disease is difficult to predict. For some patients, the disease may progress slowly, whereas for others, it may advance more rapidly. On average, the life expectancy of patients is relatively short. Even in the United States, which has some of the world's leading medical conditions, there are approximately 495 cases per 100,000 people, with a median survival estimated at 2-5 years post-diagnosis. According to statistics from the Synapse database, there are a total of 341 R&D pipelines globally in the direction of idiopathic pulmonary fibrosis, with 4 approved drugs on the market, 6 projects in phase III clinical trials, 40 projects in phase II clinical trials, and 45 projects in phase I clinical trials. GPCR-class targets that are popular research targets for this clinical indication include autotaxin, LPAR1, αvβ6, etc. BMS-986278 is a lysophosphatidic acid receptor 1 (LPAR1) antagonist developed originally by BMS Company. Extensive research indicates that idiopathic pulmonary fibrosis (IPF) can be mediated by lysophosphatidic acid (LPA), which acts through several of the six known lysophosphatidic acid receptor-mediated downstream signaling pathways. The first generation LPAR1 antagonist developed by BMS Company, represented by BMS-986020, exhibited hepatobiliary toxicity and increased plasma bile acids in a phase II clinical trial. Subsequently, BMS Company conducted preclinical studies on the mechanism of hepatic toxicity with BMS-986020 and two structurally different LPA1 antagonists (BMS-986234 and BMS-986278), further confirming that the second-generation LPA1 antagonist BMS-986278 did not show hepatobiliary toxicity in preclinical and clinical safety studies. BMS-986278 is currently in phase II clinical development for the treatment of IPF and progressive fibrotic interstitial lung diseases. In addition to BMS, companies including Sanofi, UBE, Novo Nordisk, and DJS Antibodies have also been involved in the development of drugs targeting LPAR1 for the treatment of idiopathic pulmonary fibrosis. VP01 (C-21) is an AT2R agonist developed by Vicore Pharma. The company recently published research data demonstrating that C21 can reduce the content of TGFβ1 and collagen in human IPF lung slices. In a phase 2a clinical trial, C21 showed good safety and efficacy in newly treated IPF patients, maintaining stable forced vital capacity over a 36-week treatment period. Apart from Vicore Pharma, companies including MorphoSys and Emeriti Bio are also strategizing on the development of therapeutics targeting the AT2R for the treatment of idiopathic pulmonary fibrosis. In 2017, a team from Genentech published a research paper in the journal Thorax, discussing CXCL14 as a potential biomarker for Hedgehog signaling in idiopathic pulmonary fibrosis. Compared to the control group, there is a significant increase in the expression of Hedgehog-associated genes in the lung tissue of patients with Idiopathic Pulmonary Fibrosis (IPF). The most upregulated gene in IPF lung biopsy tissues and fibroblasts subjected to SHh stimulation in vitro was CXCL14, a gene that encodes a soluble secreted chemokine whose expression is inhibited in vitro by vismodegib. Overexpression of SHh in the lungs of mice induces the expression of CXCL14. Circulating levels of CXCL14 protein in the plasma of IPF patients are significantly higher than those in the control group. In cancer patients, circulating levels of CXCL14 decreased significantly after treatment with vismodegib. Therefore, the IL-13 inhibitor Lebrikizumab, originally developed by Genentech, is considered to have potential for the treatment of IPF. Treprostinil is a prostacyclin receptor agonist originally developed by United Therapeutics for the treatment of pulmonary arterial hypertension to alleviate exercise-related symptoms. Treprostinil is a stable, synthetic analog of prostacyclin that promotes vasodilation of the pulmonary and systemic arterial beds and inhibits platelet aggregation. It helps reduce symptoms in patients with Pulmonary Arterial Hypertension (PAH) and patients with pulmonary hypertension associated with interstitial lung disease. The FDA approved Treprostinil for the treatment of PAH in 2002. The first drug approved for the treatment of PAH was epoprostenol, an artificially synthesized prostacyclin, which significantly improves the quality of life for patients. However, the use of epoprostenol has been limited due to its short half-life (3-5 minutes) and instability at room temperature. The use of Treprostinil, a more stable alternative drug, has provided PAH patients with more treatment options. In 2021, clinical study data published in The Lancet Respiratory Medicine journal indicated that, for patients with interstitial lung disease and accompanying pulmonary arterial hypertension, inhaled Treprostinil improved patients' forced vital capacity (FVC) after 16 weeks compared to a placebo. This difference was most pronounced in patients with specific types of interstitial pneumonia, particularly those with Idiopathic Pulmonary Fibrosis. Inhaled Treprostinil appears to be a promising therapy for the treatment of Idiopathic Pulmonary Fibrosis. In 2021, multiple teams jointly initiated a phase III clinical trial of Treprostinil for the treatment of idiopathic pulmonary fibrosis. Nalbuphine is a κ-opioid receptor agonist and μ-opioid receptor antagonist that was originally researched and developed by Endo International plc. Currently, this medication is undergoing a Phase II clinical trial for Idiopathic Pulmonary Fibrosis (IPF). Brilaroxazine is a 5-HT1A/5-HT2A partial agonist originally researched and developed by Reviva Pharmaceuticals and is being used for the development of various clinical indications, including schizophrenia, idiopathic pulmonary fibrosis (IPF), and pulmonary arterial hypertension. Brilaroxazine has shown promising results in a Bleomycin-induced IPF rodent model when used alone or in combination with standard therapies. At present, this drug is also undergoing a Phase II clinical trial for IPF. Setogepram (PBI-4050) is a novel orally bioavailable small molecule compound developed by Liminal BioSciences. Its mechanism of action includes being an agonist for GPR40 and an antagonist for GPR84, demonstrating anti-fibrotic activity in various fibrosis models, including pulmonary fibrosis. Data from a 12-week Phase 2 clinical trial published in 2019 evaluated the safety, efficacy, and pharmacokinetics of daily oral administration of 800 mg of PBI-4050 alone or in combination with nintedanib or pirfenidone in patients with mild to moderate idiopathic pulmonary fibrosis (IPF). The 12-week open-label study investigated the effects of PBI-4050 in monotherapy in 9 patients, combined with nintedanib in 16 patients, and combined with nintedanib or pirfenidone in another 16 patients. The pharmacokinetic profiles were similar in both the PBI-4050 monotherapy group and the PBI-4050+nintedanib combination group, whereas the pharmacokinetics were reduced in the PBI-4050+pirfenidone group. There were no significant changes in Forced Vital Capacity (FVC) from baseline to week 12 in either the PBI-4050 monotherapy or the PBI-4050+nintedanib combination group. In contrast, a statistically significant decline in the percentage of predicted FVC was observed after 12 weeks of treatment with PBI-4050+pirfenidone. The stability of FVC between baseline and week 12 when using PBI-4050 alone or in combination with nintedanib was encouraging.

16 Dec 2016

·www.biospace.com

Novartis AG Snaps Up Mid-Stage Eczema Rival

December 16, 2016 By Mark Terry , BioSpace.com Breaking News Staff Switzerland-based Novartis announced today that it is acquiring Ziarco Group Limited , a private company in the dermatology space. No financial details were disclosed. Part of the deal includes Ziarco ’s one-daily oral H4 receptor antagonist currently being developed for atopic dermatitis (AD), or eczema. ZPL389 is a potential first-in-class treatment for the disease. “There is an unmet need for innovative, effective and safe oral treatment options for people living with eczema,” said Vasant Narasimhan , global head, Drug Development and chief medical officer of Novartis, in a statement. “We are proud of our dermatology capabilities shown by the recent successful launches of Cosentyx and Xolair. Now we’re excited about a potential new medicine for people with eczema through the acquisition of Ziarco and the addition of a first-in-class H4 receptor antagonist to our growing pipeline.” John Carroll , writing for Endpoints News, points out that this is only two days after Pfizer received U.S. Food and Drug Administration (FDA) approval for an atopic dermatitis drug. “The object of (Novartis’) affection is Ziarco, a 5-year-old upstart that has gathered positive midstage data together for ZPL389, an oral drug that achieved statistically significant results for its H4 receptor antagonist. The Phase IIa delivered a 50 percent drop in EASI scores at 8 weeks, compared to 27 percent for the placebo. And the SCORAD marks registered a drop of 43 percent against 26 percent. The Phase IIb was slated to start in the second half of this year.” Pfizer ’s EUCRISA (crisaborole) ointment 2% is a non-steroidal topical phosphodieterase-4 (PDE-4) inhibitor for mild to moderate atopic dermatitis. “The approval of EUCRISA is great news for the children and adults suffering from mild to moderate eczema, a community that has not had a new prescription treatment for more than 10 years,” said Albert Bourla , group president, Pfizer Innovative Health , in a statement. “This is also an important milestone for Pfizer as we continue to build on our heritage in Inflammation and Immunology by offering innovative treatment options to patients who need them.” Particularly notable is increased interest in atopic dermatitis within the industry. Regeneron and Sanofi received priority review in late September for dupilumab, a potential blockbuster drug for atopic dermatitis. The PDUFA date is March 29, 2017. Dupilumab is an inhibitor of IL-4 and IL-13, which was supported by stellar Phase III trial results. Analysts have projected dupilumab as potentially generating annual sales of $2.5 billion to $5 billion. Other companies are also trying to edge into the market. Danish company LEO Pharma acquired the rights to AstraZeneca ’s tralokinumab earlier this year. AstraZeneca released Phase IIb data for the drug, which is an anti-IL-13 monoclonal antibody, in the first quarter of this year. Galderma Pharma acquired the rights to an anti-IL-31 receptor A monoclonal antibody from Roche ‘s Chugai Pharmaceuticals , but no data beyond Phase II has been released. In 2012, Ziarco entered into a deal with Pfizer for exclusive rights to commercialize a number of clinical, preclinical and research assets. The company was founded by Mike Yeadon , formerly vice president and chief scientific officer of Pfizer’s Allergy and Respiratory Research Unit, and three former Pfizer executives, Steve Liu , vice president and chief scientific officer, Lynn Purkins , vice president and head clinical development, and Arif Shivji , vice president and head development operations and business development. The H4antagonist program was one of the compounds Ziarco licensed from Pfizer. Pfizer Venture Investments was also one of the investors in the initial Series A financing.

Phase 2Clinical ResultPhase 3License out/inAcquisition

100 Deals associated with Dectrekumab

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Perianal fistula due to Crohn's disease	Phase 2	Switzerland	Novartis Pharmaceuticals Canada, Inc.	01 Jan 2011
Eosinophilic Esophagitis	Phase 2	United States	Novartis Pharmaceuticals Corp.	01 Nov 2009
Asthma	Phase 2	United Kingdom	Novartis Pharmaceuticals Corp.	01 Jul 2009
Keloid	Phase 2	United States	Novartis Pharmaceuticals Corp.	01 Jun 2009
Allergic asthma	Phase 2	-	Novartis AG	01 Jan 2008
Inflammation	Phase 2	Germany	Novartis AG	01 Dec 2007
Inflammation	Phase 2	United Kingdom	Novartis AG	01 Dec 2007
Pulmonary Fibrosis	Phase 2	-	Novartis Pharmaceuticals Corp.	01 Dec 2007
Rhinitis, Allergic, Seasonal	Phase 2	Germany	Novartis AG	01 Dec 2007
Rhinitis, Allergic, Seasonal	Phase 2	United Kingdom	Novartis AG	01 Dec 2007

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01022970 (Pubmed \| J Allergy Clin Immunol Pract \| J Allergy Clin Immunol) Manual	Phase 2	Eosinophilic Esophagitis	23	Dectrekumab	tlzfzkskve(wzhvjfcwlw) = ddjtmqkisa jlffhsyrwl (czpxvxkeuk, 22 - 61) View more	Positive	01 Feb 2015
				Placebo	tlzfzkskve(wzhvjfcwlw) = sauzhrywwo jlffhsyrwl (czpxvxkeuk, 1 - 43) View more

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