Glenmark Pharma announces progress in its eczema drug investigation

GBR 830 is an investigational, anti-OX40 monoclonal antibody being studied for the treatment of moderate-to-severe atopic dermatitis (AD).

PARAMUS: Pharma major, Glenmark Pharmaceuticals, announced the presentation of a new post hoc analysis of data from a Phase 2a, proof-of-concept study of GBR 830 at the American Academy of Dermatology (AAD) Annual Meeting in Washington, DC.

GBR 830 is an investigational, anti-OX40 monoclonal antibody being studied for the treatment of moderate-to-severe atopic dermatitis (AD).

The Phase 2a study was conducted to investigate the safety of GBR 830, evaluate its effects on AD biomarkers, and generate the first clinical evidence of its biological activity.

The Phase 2a study was conducted to evaluate the activity of GBR 830 in patients with intrinsic and extrinsic AD subtypes, and for subjects with elevated IgE levels at baseline. The analyses demonstrated that baseline clinical scores (EASI, SCORAD, IGA) were consistent regardless of a patient's AD subtype or whether they had elevated IgE. Reductions in SCORAD clinical scores were observed throughout the treatment period.

Mahboob Rahman, President and Chief Medical Officer at Glenmark Pharmaceuticals said, "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. We are pleased to present this evidence at AAD on the potential effectiveness of GBR 830 across subtypes, which is valuable for future clinical development and decision making."

In the study, GBR 830 was safe and well-tolerated. The most common treatment emergent adverse event was headache, with no meaningful differences observed 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.

Also Read: Glenmark Pharma gets USFDA nod for generic version of Micardis HCT tablets