Glenmark Pharmaceuticals reported encouraging results from its Phase 2 clinical trial for GBR 830, a drug that it is testing as a potential treatment for a skin disease known as atopic dermatitis.
“A clinical improvement in Eczema Area and Severity Index (EASI) scores was observed in 17 out of 23 patients treated with GBR 830,” the India-based pharmaceutical company said.
Typically, drugs go through three phases of clinical trials before they are filed for approval, with the first one looking at safety and the second one looking at both safety and efficacy.
“The Phase 2a study was not powered for statistical differences between GBR 830 and placebo, but the data suggest clinically meaningful and sustained improvement in symptoms, with consistency between biomarker and clinical responses,” it added.
“In this study we observed consistency between molecular signals of disease activity, measurable changes in skin thickening and clinical improvement in AD symptoms,” said Emma Guttman-Yassky, MD, PhD, and Director of the Center of Excellence in Eczema and Professor of Dermatology and Medicine at Icahn School of Medicine at Mount Sinai.
“These findings are encouraging and suggest that GBR 830 has an effect on atopic dermatitis mechanisms and may result in meaningful improvements for patients.”
The study also found that the drug was well-tolerated, the company said, adding that trials on the drug will continue.
“The most common treatment emergent adverse event was headache, with no meaningful differences observed between GBR 830 (13%) and placebo (25%) treated patients.”
Fred Grossman, President and Chief Medical Officer at Glenmark Pharmaceuticals said the study indicated that GBR 830 is well-tolerated and has demonstrated biological response.
“Novel, selective biologic therapies like GBR 830 hold great promise in the treatment of AD, and Glenmark is committed to rigorous further study of its mechanism and potential for clinical efficacy.”