Glenmark initiates Phase IIb dose range finding study for GRC 27864

15 Jan 2018 Evaluate

Glenmark Pharmaceuticals has been granted permission by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), Government of India, to conduct a Phase IIb dose range finding study to evaluate safety and efficacy of GRC 27864 in patients with moderate osteoarthritic pain.

GRC 27864 is a potent, selective, and orally bioavailable inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), a novel therapeutic target in pain management, which is up-regulated under inflammatory conditions.

The Phase II study is planned in India in 624 patients of osteoarthritis of the knee and hip to evaluate safety, efficacy and; biomarkers to characterize novel mechanism differentiated from existing NSAID’s and selective COX-2 inhibitors. Primary objective of the study is to evaluate safety and tolerability of GRC 27864 given orally at daily doses of 10 mg, 25 mg and 75 mg for 12 weeks compared to placebo, in patients with moderate osteoarthritic pain.

Glenmark Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).


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