Glenmark's lead candidate for pain, GRC 6211, enters Phase I in Euro

Mumbai, Dec 13 (UNI) Glenmark Pharmaceuticals today informed the BSE that Glenmark Pharmaceuticals S.A. [GPSA], the wholly owned Swiss subsidiary of the company, has applied for Phase I clinical trials in Europe, for GRC 6211, it's leading vanniloid receptor [VR1] 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. The company would also conduct a parallel study, a Proof of Concept [Phase IIA] study on patients with dental pain. The Company hopes to complete Phase 1 by June 2007 and the dental pain study by October 2007.

Glenn Saldanha, Managing Director and CEO of the Company, on this occasion commented, ''GRC 6211 is Glenmark's third and an exciting molecule to enter the clinics from it's pipeline of six NCEs. The pain-killer market is amongst the largest markets and this novel target presents an excellent opportunity.'' Dr Swaroop Kumar V V S, President, Drug Discovery&Clinical Development of the company noted, ''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.'' UNI AR WD AG1555