Glenmark’s Phase IIa study of atopic dermatitis drug shows improved symptoms


Glenmark Pharmaceuticals has reported positive results from the Phase IIa clinical trial of its investigational candidate GBR 830 in patients with atopic dermatitis.

GBR 830 is a monoclonal antibody being developed to inhibit costimulatory immune checkpoint receptor OX40 present on activated T-cells and memory T-cells to minimise inflammation associated with symptoms of the disease.

The results from the double-blind, placebo-controlled, randomised Phase IIa trial indicated clinically meaningful, continuous and sustained improvement in symptoms with a consistent biological and clinical response.

Conducted in 62 subjects with moderate-to-severe atopic dermatitis, the trial assessed the safety, biological and clinical activity, and pharmacokinetics of two GBR 830 doses over 12 weeks.

"We are pleased with the outcome of our Phase IIa study and look forward to rapidly advancing GBR 830."

Glenmark Pharmaceuticals president and chief medical officer Dr Fred Grossman said: "GBR 830 is a novel, antagonistic monoclonal antibody that is designed to selectively target OX40 receptors to reduce inflammation in atopic dermatitis.

“We are pleased with the outcome of our Phase IIa study and look forward to rapidly advancing GBR 830."

In a cohort of 23 patients, 17 are reported to have shown a 50% decrease in Eczema Area and Severity Index (EASI) scores with GBR 830 at day 57 when compared to baseline.

The overall safety profile of the investigational candidate was found to be consistent with that of placebo, while the most commonly treatment-related adverse event observed was a headache.

The firm plans to further investigate GBR 830 in a Phase IIb trial in the first half of next year.