MONTREAL, January 26, 2016 – NEOMED Institute, a public-private organization dedicated to drug discovery and the development of early stage therapeutics up to human proof of concept, announced today that Health Canada has approved NEOMED’s Clinical Trial Application (CTA) to conduct a Phase II study for its product candidate NEO6860, a TrpV1 antagonist, for the treatment of osteoarthritis pain.
The clinical trial will commence in the first quarter of 2016 and data are expected to be delivered the same year. The trial will enroll up to 50 patients with osteoarthritis of the knee. Three sites, two in Montreal and one in Sherbrooke, will participate. Using naproxen, it will be a crossover, double-blind, placebo- and active-controlled study.
“We at NEOMED are extremely proud to initiate our first Phase II study, only three years after the inception of our institution, and a few months after the successful completion of the Phase I trial,” said Dr. Dan Chiche, Vice President, Clinical Development.
Vanilloid receptor (TrpV1) antagonists were explored about a decade ago by many biopharmaceutical companies. Most trials failed because of two common side effects: dysregulation of body temperature (hyperthermia) and reduced ability to sense high temperatures, which could have resulted in burn injuries. NEO6860 is a potent, reversible, modality selective, and orally available TrpV1 antagonist. It has a uniquely different pharmacological profile, in that it blocks only the channel’s activation by capsaicin, not by heat or pH.
NEO6860 is developed for the treatment of pain associated with osteoarthritis – the most prevalent type of arthritis and a leading cause of disability in Canada. In addition, based on preclinical observations, a safe TrpV1 antagonist would open the way to clinical evaluations in multiple indications, from pain control to respiratory diseases.
In 2015, NEOMED conducted a Phase I study demonstrating that NEO6860 is safe, has an excellent pharmacokinetic profile, and is devoid of the side effects previously seen with first-generation TrpV1 antagonists.
“This program is extremely promising and the team at NEOMED has confidence that this Phase II study will demonstrate that NEO6860 is a safe and effective analgesic, critically needed by patients with osteoarthritis pain. Furthermore, NEO6860 offers the possibility of testing the potential of a TrpV1 antagonist in multiple indications where TrpV1 may play a pathological role,” added Dr. Philippe Walker, Chief Scientific Officer at the NEOMED Institute.
ABOUT THE NEOMED INSTITUTE
The NEOMED Institute is a not-for-profit organization whose mission is to create a bridge between basic research and the commercialization of new drugs by providing industrial expertise in drug discovery and development, combined with funding and a favourable ecosystem, to transform innovations into solid therapeutic solutions. NEOMED drives drug discovery activities up to the stage of human proof of concept. The NEOMED Institute has two fully integrated research and development facilities: one in Technoparc Montréal’s Saint-Laurent Campus, specializing in small molecule therapeutics, and the other facility, specializing in the development of biologics and vaccines, in Laval. Both facilities function as open-access drug discovery hubs housing independent commercial businesses and providing a dynamic environment that stimulates collaboration, innovation, and creativity.
The NEOMED Institute is jointly funded by the pharmaceutical industry, the Ministère de l’Économie, de l’Innovation et des Exportations du Québec, and the Networks of Centres of Excellence (NCE) of Canada.
To learn more, please visit our website: www.neomed.ca.
For more information, please contact:
Montreal, Quebec H4S 1Z9
514-367-1212 x 209