Lausanne – July 25, 2017– Galderma announced today the enrollment of the first patient in a multicenter double-blind Phase IIb clinical trial to evaluate nemolizumab, its investigational subcutaneous anti-IL-31 receptor A (RA) monoclonal antibody, in patients with atopic dermatitis (AD). The trial is designed to assess the efficacy of nemolizumab in moderate-to-severe AD subjects with severe pruritus receiving topical corticosteroids, who were not adequately controlled with topical treatments. Patients will be randomized to receive one of three active doses of nemolizumab or placebo administered once a month for 6 months. The safety, tolerability and pharmacokinetics of nemolizumab will also be assessed in this study.
Atopic dermatitis is a chronic inflammatory skin disease, and is the most common form of eczema which frequently begins in childhood and can last through adulthood, although in some patients it may start in adulthood. The cause of AD is not fully understood, but possibly involves multiple genetic, immune and environmental factors. Patients with AD often have dry, red, and swollen skin, and pruritus is the cardinal symptom which may lead to a very significant impact on sleep and quality of life for patients and their families.
“There are still very limited therapy options for patients with moderate-to-severe atopic dermatitis, and we hope to bring a safe and effective alternative to meet the significant remaining unmet needs for this population” said Prof. Dr. Thomas Ruzicka from Munich.
“For many years, patients with moderate-to-severe atopic dermatitis did not have an effective treatment option. Anti-IL-31 RA monoclonal antibody represents a novel treatment mechanism and we were excited by the Phase IIa study results published in NEJM earlier this year (1). We hope this trial will confirm the effectiveness and safety of nemolizumab, which will pave the way for confirmatory Phase III trials and make nemolizumab a first-in-class solution for atopic dermatitis” said Dr. Thibaud Portal, Vice-President of Galderma’s Prescription Business.
Galderma, Nestlé Skin Health’s medical solutions business, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin, hair and nails. For more information, please visit www.galderma.com
Nemolizumab is a humanized anti-human IL-31 receptor A (RA) monoclonal antibody which inhibits the binding of IL-31 to IL-31 RA and subsequent signal transduction. IL31 is a pro-inflammatory cytokine that plays a key role in pruritus, barrier disruption, and the inflammatory response in AD. Nemolizumab was created by Chugai Pharmaceutical Co., Ltd, and licensed out to Galderma for development and marketing worldwide, with the exception of Japan and Taiwan.
(1) T. Ruzicka et al., Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis, N Engl J Med 2017; 376:826-35
Sébastien Cros, Head of Corporate Communications, email@example.com