Galderma Advances Phase 3 Clinical Study with Nemolizumab in Moderate-to-Severe Atopic Dermatitis
Galderma, a global leader focused on meeting the world's increasing skin health needs, announced that it has enrolled the first patients in a new Phase 3 clinical study with nemolizumab, an investigational therapy in adult patients with moderate-to-severe atopic dermatitis.
This study is a randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of nemolizumab in subjects with moderate-to-severe atopic dermatitis.
Nemolizumab is a first-in-class investigational monoclonal antibody that blocks signaling of IL-31, a cytokine that plays a key role in the pathogenesis of moderate-to-severe atopic dermatitis. Atopic dermatitis is a serious, chronic form of eczema associated with a high burden of disease linked to itch, sleep deprivation and significant quality of life impairment.
“We are advancing the development of nemolizumab as planned. The Phase 2 results showed clear clinical benefits, adding to the growing scientific evidence that the IL-31 pathway may be an important driver in atopic dermatitis. We are committed to continuing our work to bring new therapies to patients with moderate-to-severe atopic dermatitis,” said Thibaud Portal PhD, Galderma Global Vice President, Prescription medicines.
Earlier this year, Galderma presented the final results from the Phase 2b study of nemolizumab in patients with moderate-to-severe atopic dermatitis at the 2019 American Academy of Dermatology Annual Meeting late-breaking session and published in the Journal of Allergy and Clinical Immunology in August 20191
About the IL-31 Pathway and Atopic Dermatitis
Moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema, is a systemic inflammatory disease characterized by an allergic response driven by a subset of immune cells called Type 2 helper T cells, or Th2 cells. IL-31, a cytokine released by Th2 cells, is involved in AD associated pruritus by interacting with IL-31 receptor alpha expressed by neuron. IL-31 is also thought to play a role in AD skin inflammation and AD skin barrier impairment. Moderate-to-severe forms of AD can be characterized by pronounced cutaneous dryness, and skin lesions marked by redness, infiltration/papulation, crusting/oozing, and lichenification, with periods of lesion exacerbation accompanied by intense itching, scratching, and skin damage that can lead to secondary infections. Moderate-to-severe AD can negatively impact patients’ lives and is associated with a high burden to patients particularly with itching, sleep deprivation and depression.
Nemolizumab, a first-in-class humanized monoclonal antibody, is directed against the IL-31R alpha, which blocks signaling from - IL-31. Nemolizumab, initially developed by Chugai Pharmaceutical Co., Ltd., was subsequently licensed to Galderma in 2016. Nemolizumab is an investigational agent under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.
Galderma, the world's largest independent global dermatology company, 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. For more information, please visit www.galderma.com
1. Silverberg JI, et al., Phase 2b Randomized Study of Nemolizumab in Adults with Moderate-Severe Atopic Dermatitis and Severe Pruritus, Journal of Allergy and Clinical Immunology 2019, doi: https://doi.org/10.1016/j.jaci.2019.08.013 .
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