Glenmark to start clinical trials of painkiller in Europe

14 December 2006

Mumbai: Glenmark Pharmaceuticals Ltd said on Wednesday that it is seeking permission to start clinical trials in Europe of a drug it is developing for treating pain.

Glenmark Pharmaceuticals S A, the wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd., has applied for Phase I clinical trials in Europe, for GRC 6211, its leading vanniloid receptor antagonist compound for a range of pain indications like osteoarthritis, dental pain, neuropathic pain and urinary incontinence. This study will be conducted by Kendle, a leading global CRO.

The Phase I study will be conducted using single and multiple oral doses with the objective of assessing safety and bioavailability of GRC 6211 in healthy human beings. Glenmark would also be conducting, in parallel, a proof of concept (Phase IIA) study on patients with dental pain. Glenmark hopes to complete Phase 1 trials by June 2007 and the dental pain study by October 2007.

"GRC 6211 is Glenmark''s third and an exciting molecule to enter the clinics from its pipeline of six NCEs. The pain market is amongst the largest markets and this novel target presents an excellent opportunity," Glenn Saldanha, managing director and CEO of Glenmark Pharmaceuticals Ltd., said.

"Pre-clinical studies have demonstrated GRC 6211 to be highly potent with functional IC50 of 3.8 nM and good bioavailability across species tested. The molecule also exhibited greater than 2600 selectivity over other TRP channels." Swaroop Kumar, president - drug discovery & clinical development, Glenmark, said.

Glenmark is also in discussions for potential licensing partners for this compound. The company targets launching the molecule in 2011 and aims to be an early launcher in this class.