Galderma Announces First Patient Enrollment in Study to Assess Nemolizumab in Adults With Chronic Pruritus of Unknown Origin

Author of the article:You can save this article by registering for free here. Or sign-in if you have an account.Subscribe now to read the latest news in your city and across Canada.Subscribe now to read the latest news in your city and across Canada.Create an account or sign in to continue with your reading experience.Create an account or sign in to continue with your reading experience.ZUG, Switzerland — Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the first patient enrollment for its phase II study investigating the efficacy and safety of nemolizumab in treating patients living with Chronic Pruritus of Unknown Origin (CPUO). The first patient of the trial – which is taking place in the United States – was enrolled at Dr. Vlada Groysman’s site in Birmingham, Alabama.Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againInterested in more newsletters? Browse here.CPUO is an underdiagnosed condition defined as itch lasting for more than six weeks without an identified cause.1 It is a common condition and prevalent in nearly 30% of the elderly in certain populations, but despite its debilitating impact – with effects on sleep, mental health, and overall quality of life – there are currently no approved treatments.1,7 Nemolizumab is a monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31, a neuroimmune cytokine that plays a key role in CPUO by driving itch, its main symptom.1-4 This randomized, double-blind, placebo-controlled phase II study will determine the therapeutic potential of nemolizumab in adults with CPUO, to support progression to late-stage development.8“We’re excited to launch this study exploring nemolizumab’s potential in patients with CPUO, many of whom have struggled for years without effective treatment options. Nemolizumab has shown outstanding efficacy in prurigo nodularis – a condition that shares important clinical and mechanistic features with CPUO – through its targeted inhibition of IL-31 signaling. With recent research further reinforcing IL-31 as a key driver of itch in CPUO, we’re hopeful that nemolizumab could offer meaningful relief to patients with this condition.”DOCTOR SHAWN KWATRA, M.D.LEAD INVESTIGATOR, CHRONIC PRURITUS OF UNKNOWN ORIGIN PHASE II STUDY“The first patient enrollment in this study marks an important milestone in our commitment to advancing dermatology for every skin story – especially in areas of high unmet need. CPUO is a deeply distressing condition for patients, and the absence of approved treatments has left many without options. With nemolizumab’s targeted mechanism of action and promising results in related conditions, we’re hopeful this study will pave the way for a new therapeutic approach for those living with CPUO.”BALDO SCASSELLATI SFORZOLINI, M.D., PH.D.GLOBAL HEAD OF R&DGALDERMANemolizumab was approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis.In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.To date, nemolizumab is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including in the European Union, Australia, Singapore, Switzerland and the United Kingdom. Additional regulatory submissions and reviews are ongoing.Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.10,11About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.References https://www.businesswire.com/news/home/20251210261871/en/ContactsFor further information: Christian Marcoux, M.Sc.

Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12Richard Harbinson Corporate Communications Director richard.harbinson@galderma.com +41 76 210 60 62Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43Céline Buguet Franchises and R&D Communications Director celine.buguet@galderma.com +41 76 249 90 87#distroPostmedia is committed to maintaining a lively but civil forum for discussion. Please keep comments relevant and respectful. Comments may take up to an hour to appear on the site. You will receive an email if there is a reply to your comment, an update to a thread you follow or if a user you follow comments. Visit our Community Guidelines for more information.