Glenmark Pharmaceuticals’ first in class Transient Receptor Potential Ankyrin 1 (TRPA1) antagonist, GRC 17536 has shown positive data in a phase 2a double blind, placebo controlled, multi-centre, proof of concept study conducted on 138 patients in Europe and India.
A statistically significant and clinically relevant response was seen in a prospectively-identified, substantial sub-group of patients with moderate to severe pain who had relatively intact sensory responses as detected by a standardised testing methodology. GRC 17536 was well-tolerated with no evidence of CNS or other drug related side effects.
Patrick Keohane, Chief Medical Officer, Glenmark stated, “Diabetic neuropathy remains a difficult to manage chronic clinical condition with limited therapeutic options. These initial efficacy and safety data with GRC 17536, a peripherally acting novel therapeutic, are encouraging, and Glenmark intends to be ready to file for a phase 2b dose range finding study in patients with neuropathic pain before the end of this financial year. This announcement also reaffirms our position globally in the development of novel pain therapies.”
Commenting on the result, Dr Michael Buschle, Chief Scientific Officer & President – Biologics, Glenmark Pharmaceuticals mentioned, “This is promising and GRC 17536 may be useful for several indications which we will pursue.”
The Glenmark TRPA1 programme includes indications in pain as well as respiratory. inhaled doses of GRC 17536 are also being tested in a phase 2A proof of concept study in patients with chronic cough.
TRPA1 is an ion channel expressed on peripheral and spinal sensory neurons and it mediates pain signal transmission. It functions as a cellular sensor for detecting painful mechanical, biochemical and thermal stimuli that cause sensory nerve hyperactivity during chronic pathologies including chronic pain, inflammation, itch and cough.
EP News Bureau – Mumbai