Cogentus Initiates Trial Of Novel Combination Medicine
The first patient has been enrolled in Cogentus Pharmaceuticals's pivotal Phase 3 study of its novel combination medicine CGT-2168. The patient entered the study at the Mobile Heart Specialists P.C. in Mobile, Ala.
The study will evaluate the antiplatelet medicine CGT-2168, which is a combination of clopidogrel (currently marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis as Plavix) and a gastroprotectant (omeprazole) in a single pill. Developed by Cogentus, CGT-2168 is designed to provide protective cardiovascular benefits while reducing potentially serious gastrointestinal side effects commonly associated with dual antiplatelet therapy.
"This is an important milestone for Cogentus that holds promise for the millions of patients who are prescribed dual antiplatelet treatment," said Cogentus Chairman and Chief Executive Officer Mark A. Goldsmith, M.D., Ph.D. "We believe CGT-2168 has the potential to reduce significantly the gastrointestinal side effects that can cause patients to interrupt their treatment and further compromise their health status."
Antiplatelet therapy is an integral part of treating patients with acute coronary syndrome and has been shown to be effective in preventing major cardiovascular events. However, the combination of clopidogrel and aspirin is associated with gastrointestinal bleeding, which in some cases requires hospitalization and can even result in death.
The global trial is known as COGENT-1 (Clopidogrel and the Optimization of Gastrointestinal Events Trials) and is part of a clinical program expected to enroll more than 4,000 patients at hundreds of sites in the United States, Canada, Europe and South America.
Among patients who participate in the study, approximately half will receive clopidogrel and aspirin; the other half will receive CGT-2168 (clopidogrel plus omeprazole) and aspirin. Patients will be assessed regularly for any gastrointestinal side effects such as bleeding and ulcers as well as receive ongoing monitoring of their cardiovascular status.