Kitov's KIT-302 meets Phase III endpoint, bettering amlodipine besylate

Israel-based Kitov Pharmaceuticals (TASE: KTOV) said today that the Phase III, double-blind, placebo-controlled clinical trial for its leading drug candidate, KIT-302, successfully met the primary efficacy endpoint of the trial protocol as approved by the US Food and Drug Administration.

Data from the trial further revealed that KIT-302 was more efficacious at reducing hypertension than the widely used hypertension drug amlodipine besylate. Kitov plans to file its New Drug Application (NDA) for marketing approval of KIT-302 with the FDA in the second half of 2016. The news pushed Kitov’s shares 45.7% higher to 102.00 Israeli shekel.

A combination drug, KIT-302, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex, from Pfizer) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension.