India-based Glenmark Pharmaceuticals has reported that its candidate for neuropathic pain, osteoarthritis and other inflammatory pain disorders – GRC 10693, has successfully completed Phase I trials in Europe.
The Phase I study was conducted on 80 healthy human subjects using escalating single and multiple oral doses with the objective of assessing safety, tolerability and pharmacokinetics of GRC 10693. The highest single dose achieved in the study was 1200mg.
According to Glenmark, the study demonstrated that GRC 10693 was well tolerated by the subjects at all dose levels and was found to have a dose proportional pharmacokinetic profile with good exposure levels. The latter cohort received 300mg of GRC 10693 once daily for 14 days and achieved exposure levels equivalent to those in the highest tested single dose.
In the Phase I studies, high exposure levels of the drug were reached, which exceeded by several folds the levels required for efficacy in various in vivo acute and chronic pain models in animals. In addition, several well validated pain models included in the study for confirmation of proof of mechanism in the multiple dose phase, demonstrated significant improvements in various pain scores at both two and 13 days, the key efficacy timepoints defined in the protocol, said Glenmark.
Initially, the company intends to develop GRC 10693 in neuropathic pain as the primary indication, with Phase IIb trials planned to be initiated later in 2009.
Glenn Saldanha, CEO of Glenmark, said: This is a significant achievement for our organization as GRC10693 will be our fourth molecule which will enter Phase II trials. We are very excited with the results from the Phase I studies of GRC 10693. It offers a novel treatment approach to pain and has attracted a lot of scientific and commercial interest.