Glenmark's molecule for pain disorders clear Phase I trials in Europe

13 April 2009

Glenmark Pharmaceuticals' new drug candidate for neuropathic pain, osteoarthritis and other inflammatory pain disorders, GRC 10693, has completed Phase I trials in Europe, the company announced today.

The trial was conducted on 80 healthy human subjects using escalating single and multiple oral doses with the objective of assessing safety, tolerability and pharmacokinetics of the new drug, the company said in a release.

''This is a significant achievement for our organisation as GRC10693 will be our fourth molecule which will enter Phase II trials,'' said Glenn Saldanha, managing director and CEO, Glenmark, adding that it offers a novel treatment approach to pain and has attracted a lot of scientific and commercial interest.''

The highest single dose achieved in the study was 1,200 mg. The study demonstrated that GRC 10693 was well tolerated by the subjects at all dose levels. There were no serious or significant adverse events, including no significant cardiovascular effects.

The molecule has completed the battery of pre-clinical studies and has demonstrated favorable results, a good safety margin and also exhibited superior efficacy in in-vivo models of neuropathic and inflammatory pain. It is targeted to launch by 2014.

''The design of this Phase 1 study allowed us to establish a very good therapeutic window by evaluating not just the pharmacokinetics and safety, but also by obtaining an early lead on the proof of mechanism,'' said Dr John Efthimiou, president clinical R&D & CMO of Glenmark.