Glenmark's novel monoclonal antibody GBR 900 for treatment of chronic pain entering human trials

MUMBAI, April 29, 2014 /PRNewswire/ --

• GBR 900 is a first in class monoclonal antibody for the treatment of chronic pain targeting TrkA, the receptor of nerve growth factor (NGF)
• The antibody has successfully completed the Phase I enabling preclinical development programme and a Phase I clinical trial application has been filed with the MHRA, UK
• Preclinical head to head comparisons with anti-NGF antibodies suggest that GBR 900 will have at least comparable clinical efficacy in inflammatory pain (e.g. Osteoarthritis) and a broader efficacy potential in additional disease states paired with a superior safety profile compared to anti-NGF antibodies

Glenmark Pharmaceuticals S.A., a wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd., announced today that GBR 900, a novel monoclonal antibody is entering human trials. GBR 900 targets TrkA, a receptor for nerve growth factor (NGF) involved in chronic pain signaling.

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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.

In the GLP toxicity studies no dose limiting toxicities were detected with GBR 900, even at high doses tested. This potentially differentiates GBR 900 from anti-NGF antibodies which are dose limited in clinical studies by preclinical toxicity findings at low doses.

Preclinical head to head comparisons with anti-NGF antibodies in animal models of inflammatory pain demonstrated that GBR 900's efficacy profile compares favorably with anti-NGF antibodies.

Commenting on the progress with GBR 900, Dr. Michael Buschle, President of Biologics and Chief Scientific Officer, Glenmark Pharmaceuticals Ltd. said: "Since we licensed the TrkA IP from Lay Line Genomics we have been able to differentiate GBR 900 from anti-NGF antibodies. We are very excited about the Phase I clinical study starting and expect that this study will extend the preclinical differentiation into a drug which will be clinically differentiated from anti-NGF antibodies."

"We are extremely pleased that Glenmark has made significant progress with the anti-TrkA project and are excited about the potential start of the first clinical trial of GBR 900," said Ennio Esposito, Sole Director at Lay Line Genomics S.p.A ., Italy.

About Glenmark Pharmaceuticals Ltd 

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company and ranked among the top 80 Pharma & Biotech companies of the world in terms of revenues. Glenmark is a leading player in the discovery of new molecules both NCEs and NBEs. Glenmark has several molecules in various stages of clinical development and primarily focused in the areas of Inflammation, Pain and Oncology. The company has significant presence in branded formulations across emerging economies including India. Its subsidiary, Glenmark Generics Limited services the requirements of the US and Western Europe markets.

About Lay Line Genomics S.p.A 

Lay Line Genomics S.p.A. (Italy) is a private biotechnology company focused on the discovery and development of new drugs and innovative therapies for Alzheimer's and other neurological diseases. Founded in 2001 as a spin out of the International School of Advanced Studies (SISSA) in Trieste, LLG has developed an innovative pipeline of biopharmaceuticals to take into clinical development.

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