Galderma, a Nestle-owned Swiss pharma company, said that it has enrolled the first patients in a phase 3 clinical study evaluating nemolizumab for the treatment of moderate-to-severe atopic dermatitis.
The late-stage clinical trial will feature adult patients, who are randomly grouped in a double-blinded, placebo-controlled study that will assess the efficacy and safety of the investigational drug for the skin disease.
Nemolizumab is a monoclonal antibody that inhibits signaling of IL-31, which is a cytokine known for playing a significant role in the pathogenesis of moderate-to-severe atopic dermatitis.
Originally developed by Chugai Pharmaceutical, nemolizumab was licensed subsequently in 2016 to Galderma.
Atopic dermatitis is considered to be a serious, chronic form of eczema associated with a high burden of disease linked to itch, poor quality of sleep, and substantial quality of life impairment.
Thibaud Portal – Galderma Global Vice President, Prescription medicines, said: “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.”
At the 2019 American Academy of Dermatology Annual Meeting, Galderma released the final results from a phase 2b clinical trial of nemolizumab in patients with moderate-to-severe atopic dermatitis, which has been published in the Journal of Allergy and Clinical Immunology recently.