Phase 2a study shows efficacy for atopic dermatitis treatment

Glenmark Pharmaceuticals has announced positive data from its phase 2a study of GBR 830, an investigational anti-OX40 monoclonal antibody for treating atopic dermatitis.

In the double-blind, placebo-controlled study, researchers randomly assigned 62 patients (52% male) with moderate-to-severe atopic dermatitis to measure the safety, biological and clinical activity and prokinetics of GBR 830 over 12 weeks, according to a news release.

Thirty-one patients were evaluated on multiple endpoints following the last study visit, after receiving two doses with two viable biopsies.

Seventeen out of 23 patients in the GBR 830 cohort experienced at least a 50% reduction in the Eczema Area and Severity Index (EASI) scores at day 57 when compared to baseline, according to the release.

Improvement in clinical response time was also supported by EASI 75 scores, according to the release.

GRB 830 had a similar safety profile to placebo, with headache reported as the most common adverse event.

“Although not powered for statistical differences between GBR 830 vs. placebo, data from this analysis suggest clinically meaningful improvement of symptoms that is continuous and sustained, with consistency observed between biological and clinical response,” Glenmark reported in the release.

Study data will be submitted for upcoming scientific meetings and publication in peer-reviewed journals, Glenmark reported.

The pharmaceutical company also announced that based on the results of the study, it plans to initiate a phase 2b study in 2018.

Reference: www.glenmarkpharma.com