Glenmark initiates Phase IIb dose range finding study

The study will evaluate safety and efficacy of GRC 27864 in patients with moderate osteoarthritic pain

Glenmark Pharmaceuticals, a global pharmaceutical company, 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.

Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals says, “We are excited that GRC 27864 is moving forward in clinical development and this validates our focus and commitment to develop potential first-in-class molecules. In spite of several available treatment options, there is significant unmet medical need in chronic pain. We believe that GRC 27864, through its novel mechanism of action, will be able to potentially improve patients’ quality of life.”

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.

DCGI granted permission to conduct the Phase II study based on the results of three Phase I studies conducted in healthy adult and elderly volunteers. Single oral dose up to 1000 mg and multiple oral doses up to 130 mg/day (for 28 days) of GRC 27864 were well tolerated in these studies without any dose limiting adverse events. Pharmacodynamic biomarker data generated in phase 1 studies also demonstrated adequate target inhibition.