Positive Phase 2b nemolizumab results from Galderma

LAUSANNE, Switzerland—Today Galderma, Nestlé Skin Health’s medical solutions business, has declared positive results from a Phase 2b dose-ranging study of nemolizumab in adult patients with moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema. Nemolizumab, an investigational subcutaneous anti-IL-31 receptor A monoclonal antibody, is directed against the IL-31R alpha, which blocks IL-31 signaling. Initially developed by Chugai, nemolizumab was subsequently licensed to Nestlé Skin Health in 2016.

Nemolizumab met the primary endpoint of a greater improvement in Eczema Area and Severity Index (EASI) scores from baseline compared to placebo, and met secondary endpoints of major significance to Quality of Life improvement, such as Peak Pruritus Numerical Rating Scale (NRS) score vs. baseline for example.

“These clinical data, coupled with previous phase 2a results from our licensing partner Chugai, support the growing scientific evidence that the IL31 pathway may be an important driver in atopic dermatitis. These results clearly support dose selection and will allow us to pursue the development as planned. We confirm our intent to progress nemolizumab into phase 3 in 2019,” said Thibaud Portal, PhD, Vice President of Galderma’s Prescription business.

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. Moderate-to-severe atopic dermatitis is 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 neurons, and is also thought to play a role in AD skin inflammation and AD skin barrier impairment.

Moderate-to-severe forms of atopic dermatitis 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 atopic dermatitis can negatively impact patients’ lives and is associated with a high burden to patients, particularly with itching, sleep deprivation and depression.