Glenmark Pharmaceuticals has registered its candidate GRC 15300, for osteoarthritic pain, neuropathic pain, and other inflammatory pain conditions, 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 Medicines and Healthcare Products Regulatory Agency (MHRA), UK. Glenmark expects to complete Phase I trials for GRC 15300 and initiate Phase II before the end of the year. This will be the company's seventh molecule in clinical trials.
The company claims that GRC 15300 will be the first TRPV3 molecule to enter clinics globally. The highlight for this research program 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.
Glenn Saldanha, MD & CEO, Glenmark Pharmaceuticals 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."
There has been significant scientific interest and commercial attention devoted to the vanilloid receptors as potential pain targets. Several companies have active programs in the TRPV3 space including Pfizer which entered into a collaboration agreement with Hydra Biosciences in 2007 that included potential milestone payment of upto $195 million for the first developed product launched, with upside potential for additional approved indications.
According to World Health Organisation (WHO) reports, the neuropathic pain market is estimated at around $5 billion with over 40 million patients worldwide while the osteoarthritis market is valued at over $5 billion with over 200 million patients worldwide. It is estimated that 9.6% of men and 18.0% of women aged over 60 years have symptomatic osteoarthritis.