Glenmark Pharmaceuticals Ltd (GPL) announced that its candidate for Osteoarthritic pain, Neuropathic pain, and other Inflammatory pain conditions - GRC 15300 has been filed for phase-I trials. The company intends to develop GRC 15300, a Transient Receptor Potential Vanilloid (TRPV) 3 Antagonist in neuropathic pain as the primary indication. The molecule has been filed for phase-1 approval with MHRA (Medicines and Healthcare Products Regulatory Agency), United Kingdom. Glenmark expects to complete phase-I trials for GRC 15300 and initiate phase-II before the end of CY 2009.
GRC 15300 will be the first TRPV3 molecule to enter clinics globally. With this molecule being filed for phase-I trials, Glenmark has demonstrated its strengths in the TRP area and will have one of the most in-depth research programs in TRP channels globally. The highlight for this research programme is that the TRPV3 target acts in a different temperature range devoid of hyperthermia issues, contrary to some of the TRPV1 antagonists, currently in development. GRC 15300 is highly efficacious as compared to current Gold standard molecules (Pregabalin, Gabapentin), as seen in animal models. Another positive for this molecule is that it is non-habit forming and presents a better option for chronic pain therapy.
Speaking on this development, Glenn Saldanha, MD & CEO, Glenmark Pharmaceuticals Ltd said, "We are extremely glad to take GRC 15300 forward into phase-I trials. This is a significant development for our organization as this molecule will be the first TRPV3 antagonist globally to be filed for phase-I trials making it a potential first-in-class. This development is a reaffirmation of Glenmark's research capabilities and focused approach towards drug discovery and our commitment towards setting new benchmarks in speed, efficiency and continuous progress in the drug discovery space."
GRC 15300 carries a first-in-class potential with a target launch date of 2015. It is a novel, potent and selective human transient receptor potential vanilloid (TRPV-3) receptor antagonist, has completed the battery of pre-clinical studies and has demonstrated favourable results, a good safety margin and also exhibited superior efficacy in in-vivo models of neuropathic & inflammatory pain.