GBR 830_Phase 2a study by Glenmark shows efficacy for atopic dermatitis treatment
In another milestone for Indian pharmaceutical major
Glenmark Pharmaceuticals, the company 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.
Comments
Post a Comment