Date: 2014-09-17
Type of information: Interim results
phase: 2a
Announcement: interim results
Company: Glenmark Pharmaceuticals (India)
Product: GRC 17536
Action
mechanism: GRC 17536 is a first in class TRPA1 antagonist. 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. TRPA1 receptor is shown to induce pain hypersensitivity in animal models of diabetic neuropathic pain and its blockade attenuates pain hypersensitivity as well as later loss of the nerve fibers and their function . Preclinical studies have demonstrated its effectiveness in animal models of neuropathic and inflammatory pain including the peripheral diabetic neuropathic pain, osteoarthritic pain, postoperative pain and chemotherapy induced pain which supports potential utility of TRPA1 blockade in therapeutic pain management.
Disease: diabetic neuropathy
Therapeutic area: CNS diseases - Metabolic diseases
Country: Czech Republic, Germany, India, UK
Trial
details: This Phase II, 4-week randomised, double-blind,parallel group, placebocontrolled is a proof of concept study to evaluate efficacy, safety and tolerability of GRC 17536 in patients with painful diabetic peripheral neuropathy.The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity. (NCT01726413)
Latest
news: * On September 17, 2014, Glenmark Pharmaceuticals announced that its 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 standardized testing methodology. GRC 17536 was well-tolerated with no evidence of CNS or other drug related side effects. Glenmark now intends to file for a Phase 2b dose range finding study in patients with neuropathic pain before the end of this financial year. The Glenmark TRPA1 program 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.
