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ARTICLE | Clinical News

Glenmark reports Phase IIa data for anti-OX40 mAb in atopic dermatitis

March 2, 2018 6:39 PM UTC

Glenmark Pharmaceuticals Ltd. (NSE:GLENMARK; BSE:532296) reported data from a placebo-controlled Phase IIa trial in over 60 patients with moderate to severe atopic dermatitis showing that GBR 830 reduced mRNA biomarkers of disease activity, including S100 calcium binding protein A12 (S100A12) and keratin 16 (KRT16). Additionally, 17 of 23 evaluable patients who received GBR 830 achieved a clinical improvement in Eczema Area and Severity Index (EASI) score. The company said the trial was not powered to detect significant differences between GBR 830 and placebo. GBR 830 was well tolerated with headache reported as the most common treatment-emergent adverse event. Data were presented at the American Academy of Dermatology meeting in San Diego.

Patients in the double-blind, U.S. and Canadian trial received placebo or 10 mg/kg IV GBR 830 on days 1 and 29. The trial's primary endpoints are safety and the change from baseline in active atopic dermatitis mRNA expression signatures measured from skin biopsies. Secondary endpoints include EASI and Investigator’s Global Assessment (IGA) scores...