On 4 March 2016, late-breaking research was presented on Chugai’s nemolizumab for the treatment of patients with moderate-to-severe atopic dermatitis at the 75th Annual American Academy of Dermatology (AAD) meeting.
Nemolizumab is a humanised monoclonal antibody that inhibits interleukin 31 receptor alpha (IL-31RA), with the potential to reduce or eliminate clinical disease by neutralising the viral strains responsible for dermatitis. In a 12 week Phase II study, nemolizumab demonstrated improved score in both pruritus and atopic dermatitis, potentially addressing an unmet need in atopic dermatitis for novel systemic therapies.
In the long-term extension of the Phase II randomised, double-blind, placebo-controlled study, nemolizumab maintained improvements in both pruritus and atopic dermatitis scores through Week 64. Following the 12 week Phase II study, 191 patients were randomised to receive 0.1mg/kg, 0.5mg/kg, or 2.0mg/kg of subcutaneous nemolizumab once every four weeks or 2.0mg/kg once every eight weeks for 52 weeks. At Week 64, 75.9% (22/29), 96.2% (25/26), 75.0% (21/28), and 77.8% (14/18) of patients treated with 0.1mg/kg, 0.5mg/kg, or 2.0mg/kg of nemolizumab once every four weeks or 2.0mg/kg once every eight weeks achieved pruritus visual analogue score <30mm (no or mild itch) respectively.
Further, 67.7% (21/31), 67.9% (19/28), 65.5% (19/29), and 73.7% (14/19) of patients reached a 75% reduction in Eczema Area and Severity Index (EASI75) at Week 64, respectively. It is important to note that approximately 50% of patients used on-demand concomitant topical corticosteroids, which may have resulted in an increase in EASI75 response.
Although nemolizumab could gain access to a total of approximately eight million drug-treated mild-to-moderate patients across the seven major pharmaceutical markets (US, France, Germany, Italy, Spain, UK, and Japan) by 2024, competition in the atopic dermatitis market is rapidly growing, with the recent approval of Pfizer’s Eucrisa (crisborole ointment 2%) and the anticipated approval of Regeneron/Sanofi’s Dupixent (dupilumab), not to mention over a dozen of drugs in Phase II and III development.
That being said, patients and physicians alike would welcome the addition of nemolizumab to the atopic dermatitis treatment algorithm, given the lack of systemic therapies in the disease space.