Glenmark’s NCE ‘GRC 17536’ successfully completes Phase I trials in Europe

Glenmark Pharmaceuticals Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 532296 | NSE: GLENMARK

14 Feb 2012 Evaluate

Glenmark Pharmaceuticals’ (Glenmark) novel chemical entity (NCE) ‘GRC 17536’ has successfully completed Phase I trials (single ascending dose and multiple ascending dose) in the Netherlands. GRC 17536 is a global first-in-class program targeting the TRPA1 receptor antagonists for pain and respiratory disorders. TRPA1 belongs to transient receptor potential (TRP) family of ion channels, which have generated a lot of interest as pain targets due to their distinguishing role in peripheral and/or central pain signal transmission.

Glenmark has now planned to initiate Phase II studies in pain indications. The company has filed regulatory submissions with the MHRA, UK, and BfArM, Germany, to initiate Phase 2a proof-of-concept study in patients with painful diabetic peripheral neuropathy. This double-blind, parallel group, placebo controlled study is designed to provide efficacy endpoints upon several weeks of dosing. The projected start of the study is March 2012, subject to regulatory approvals.

Additionally, GRC 17536 will be tested via the inhaled route for use in the respiratory indications. The company has observed good efficacy for GRC 17536 when administered via inhaled route in preclinical pharmacology studies. Phase 1 enabling toxicity studies via inhalation route for GRC 17536 are nearing completion. Glenmark aims to initiate human inhalation studies by June 2012 with an integrated Phase 1/2a protocol in healthy adult volunteers and mild asthmatics followed by an allergen challenge study in patients with mild asthma.

Glenmark Pharmaceuticals, a leader among the emerging market companies in drug discovery and development and most of its active substances in the pipeline are first-in-Class. Glenmark’s achievements over the year include a major deal with Sanofi in Crohn's disease, completing Phase II trials of its first novel product, crofelemer and demonstrated higher sales and profit growth.

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