Glenmark Pharmaceuticals, a pharmaceutical company headquartered in Mumbai, reported progress in a proof-of-concept study of GBR 830, being studied as a treatment for atopic dermatitis, commonly known as eczema.
The company said it was able to notice a decline in atopic dermatitis score during the study involving 62 patients, which also showed that the drug was well tolerated. Atopic dermatitis makes the skin red and itchy, and is commonly found in children.
“These responses were observed shortly after the first dose of GBR 830 and maintained through the study period and beyond,” the company said.
The Phase 2a study was conducted to investigate the safety of GBR 830, evaluate its effects on atopic dermatitis biomarkers, and generate the first clinical evidence of its biological activity. Glenmark said reductions in in atopic dermatitis scores were observed throughout the treatment period, across all subtypes of the disease.
“The consistent effect of GBR 830 observed across AD subtypes is important because not all AD therapies are effective or appropriate for all patients, thus increasing the need for precision in diagnosis and treatment,” said Mahboob Rahman, President and Chief Medical Officer at Glenmark Pharmaceuticals, adding that the results of the pilot study would help the company to make decisions about future clinical development of the drug.
The most common treatment emergent adverse event was headache. The was no meaningful differences observed in headache levels between GBR 830 (13%) and placebo-treated (25%) patients.
A Phase 2b clinical trial of GBR 830 in moderate-to-severe AD is underway and currently enrolling patients in the U.S. and Europe, Glenmark added.