Glenmark’s novel monoclonal antibody GBR 900 to enter into human trials

29 Apr 2014 Evaluate

Glenmark Pharmaceuticals S.A., a wholly owned Swiss subsidiary of Glenmark Pharmaceuticals, announced that GBR 900, a novel monoclonal antibody is entering into human trials. GBR 900 targets TrkA, a receptor for nerve growth factor (NGF) involved in chronic pain signaling. In 2010, Glenmark gained an exclusive worldwide license from Lay Line Genomics S.p.A. (Italy) for anti-TrkA antibodies and their entire intellectual property portfolio in the TrkA field. GBR 900 is the optimized anti-TrkA antibody emerging from this exclusive worldwide license.

Glenmark has now completed the Phase I enabling preclinical development programme for GBR 900 and has filed a Phase I clinical trial application with the MHRA, UK. GBR 900 is the first anti-TrkA monoclonal antibody to enter clinical development. TrkA is the pain-signalling receptor for NGF. Monoclonal antibodies directed against NGF represent one of the rare clinical breakthroughs in chronic pain treatment and have shown excellent clinical activity in inflammatory and neuropathic pain. Unfortunately, development of the class has been curtailed due to suspected toxicity.

Glenmark’s current portfolio consists of 90 products authorized for distribution in the US marketplace and 53 ANDA’s pending approval with the USFDA. In addition to these internal Filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

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