The first subject has been dosed in EASE, a Phase 2a clinical proof-of-concept study of EP262 in atopic dermatitis.

The first subject has been dosed in EASE, a Phase 2a clinical proof-of-concept study of Escient Pharmaceuticals’ EP262 in atopic dermatitis (AD).

By blocking activation of MRGPRX2 and degranulation of mast cells, EP262 has the potential to effectively treat multiple mast cell mediated diseases with an initial focus on chronic urticaria and atopic dermatitis. EP262 represents a novel, targeted approach to the treatment of these disorders with the potential for once-daily oral administration without the side effects observed with other approaches.

EASE is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability and pharmacodynamics of EP262 in approximately 30 patients with moderate to severe AD. Patients will be randomized, in a 2:1 ratio, to treatment with EP262 150 mg, or placebo, administered orally, once daily for 6 weeks, followed by an off-treatment follow-up period. The study will evaluate clinical scores as well as histological and transcriptomic markers in lesional skin biopsies. 

In preclinical studies, in a well-established mouse model (HDM/SEB) that replicates several key features of human AD, oral treatment with EP262 improved AD-like skin lesions and markers of type 2 inflammation. Notably, the preclinical efficacy observed with EP262 treatment was comparable to that of anti IL4 treatment in this model.

“With the initiation of our EASE clinical proof-of-concept study, we look forward to evaluating whether the promising preclinical findings with EP262 translate to patients with atopic dermatitis,” says Christian Weyer, M.D., M.A.S, Chief Medical Officer at Escient, in a news release. “If successful, EP262 could become a well-differentiated, once daily oral treatment option.”

More information about this study is available on www.clinicaltrials.gov (Identifier: NCT06144424).