Glenmark Pharmaceuticals S.A. [GPSA], the wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd. [Glenmark], has applied for phase I clinical trials in Europe, for GRC 6211, its leading vanniloid receptor [VR1] antagonist compound for a range of pain indications like osteoarthritis, dental pain, naturopathic 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 by June 2007 and the dental pain study by October 2007, said a company press release.
Glenn Saldanha, managing director and CEO of Glenmark Pharmaceuticals Ltd., on this occasion commented, "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".
Dr Swaroop Kumar V V S., president - drug discovery & clinical development, Glenmark stated, "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."
Glenmark is also in discussions for potential licensing partners for this compound. Timing of the licensing would depend on the deal terms and ability to get co-promotion rights in some of the regulated markets. The Company targets launching the molecule in 2011 and aims to be an early launcher in this class. Other molecules in the same category currently under development include: Merck's lead molecule which is in-licensed from Neurogen and has progressed to phase II, GSK's molecule presently in phase II and Pfizer's in-licensed compound from Renovis which is undergoing pre-clinicals trials.