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India’s Glenmark to test new pain drug GRC 17536 on humans by 2011

Monday, August 30, 2010, 20:10 This news item was posted in Clinical Trials, Featured category and has 0 Comments so far.

India’s Glenmark Pharma may soon start human testing of its a new pain drug lead compound code-named GRC 17536, the company announced.

GRC 17536 is a novel chemical entity (NCE) which targets TRPA1 receptor antagonists for pain and respiratory disorders.
A member of Transient Receptor Potential (TRP) family of ion channels, TRPA1 plays a key role in peripheral and central pain signal transmission.

Glenmark has completed preclinical studies of GRC 17536 and is in the process of finishing up phase 1 enabling GLP studies.
The Mumbai-based Glenmark plans to submit the phase 1 application for GRC 17536 in January 2011.

“We are glad to announce our third novel molecule discovery in the TRP space. Both our earlier TRP molecules i.e. TRPV1 and TRPV3 resulted in outlicensing deals for the company. GRC 17536 which is a TRPA1 receptor antagonist is another potential first-in-class globally and we are encouraged by the results shown by the molecule in animal studies. GRC 17536 is highly selective even when compared with other TRPs and can be administered orally,” stated Glenn Saldanha, CEO & managing director, Glenmark.

GRC 17536 is found highly efficacious in treating inflammatory and neuropathic pain in animal models compared to other therapies used currently.

GRC 17536 is more selective than other TRPs and can be taken orally. GRC 17536 could reverse hyperalgesia in animal models of Freund’s complete adjuvant – induced inflammatory and chronic constriction injury (CCI) – induced neuropathic pain with an EC50 of less than 10 mg/kg.

The lead compound also showed promising effect on airway inflammation, bronchoconstriction and cough, Glenmark said in an official release.

GRC 17536 has shown good safety in pharmacology and toxicology studies.

Glenmark has discovered several distinct scaffolds of TRPA1 antagonists with drug-like properties. The Mumbai-based company has filed patent applications for these molecules.

Glenmark has already conducted studies on TRPV1 and TRPV3 receptors.

Glenmark’s molecule for neuropathic pain, osteoarthritis – GRC 10693, was to enter Phase I trials last year. GRC 10693 was Glenmark’s fifth molecule to enter clinical trials.

Glenmark initiated Phase I studies for GBR 500 – a novel biologic molecule – by filing its IND application with the US-FDA, in 2008.

GBR 600, an anti-platelet monoclonal antibody, received approval from MHRA, UK to commence Phase I studies.

In May, Glenmark Pharmaceuticals S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals has entered into an agreement with Sanofi-aventis to grant Sanofi-Aventis a license for the development and commercialization of novel agents to treat chronic pain, the company announced in press release.

Glenmark’s pain drug candidates portfolio consists the new class of agents called vanilloid receptor (TRPV3) antagonist molecules. This includes Glenmark’s first-in-class clinical compound, GRC 15300.

GRC 15300 is currently in phase I clinical development as a potential next-generation treatment for various pain conditions, including diabetic neuropathic pain and osteoarthritic pain.

Under the terms of the agreement, Glenmark will receive an upfront payment of US $20 million, as well as development, regulatory and commercial milestone payments. All such payments could reach a total of U.S. $ 325 million. In addition, Glenmark is eligible
to receive tiered double-digit royalties on sales of products commercialized under the license.

Sanofi-aventis will have exclusive marketing rights for North America, European Union and Japan subject to Glenmark’s right to co-promote the products in the United States and five Eastern European countries.

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