New Delhi: Drug major Glenmark Pharmaceuticals announced the initiation of phase 2b clinical trial of GBR 830, a novel investigational treatment for moderate-to-severe atopic dermatitis.
“The trial’s primary endpoint will assess the efficacy of GBR 830, compared to placebo. Secondary and exploratory trial endpoints include additional measures of efficacy, safety and pharmacodynamics,” the company said in a BSE filing.
Trial enrollment is expected to begin in June 2018, it added.
Glenmark Pharmaceuticals President and Chief Medical Officer Fred Grossman said the results of the phase 2a trial completed last year demonstrated that GBR 830 was well-tolerated, and suggested signals of efficacy in the treatment of moderate-to-severe atopic dermatitis.
Glenmark said in addition to moderate-to-severe atopic dermatitis, the company is also evaluating the potential for conducting studies with GBR 830 for the treatment of other inflammatory autoimmune conditions.
Preparations for a clinical trial assessing GBR 830 for the treatment of systemic lupus erythematosus (SLE) are currently underway.