Product Designed To Reduce Bleeding Side Effect Of Antiplatelet Therapy
Cogentus Pharmaceuticals is launching a global Phase III clinical program to evaluate the efficacy and safety of its novel combination therapy CGT-2168.
The program, which includes the COGENT-1 and COGENT-2 trials, will enroll over 4,000 patients at hundreds of sites in the United States, Canada, Europe and South America.
CGT-2168 is a unique once-daily pill that combines the antiplatelet agent clopidogrel (currently marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis as Plavix) with a gastroprotectant (omeprazole). The product is designed to significantly reduce the gastrointestinal side effects commonly associated with antiplatelet therapy.
COGENT stands for the Clopidogrel and the Optimization of Gastrointestinal Events Trial. The COGENT trials are designed to measure the incidence of upper gastrointestinal bleeding and ulcers in patients who take CGT-2168 and aspirin compared with patients who take clopidogrel and aspirin. The vast majority of patients who take clopidogrel also take aspirin.
Antiplatelet therapy is an integral part of treating patients with cardiovascular disease, including acute coronary syndrome, and has been shown to be effective in preventing major cardiovascular events. However, treatment with antiplatelet medicines such as clopidogrel, aspirin or the frequent combination of the two is associated with gastrointestinal bleeding, which in some cases can require hospitalization and even result in death.
"The benefits of antiplatelet therapy are well established, but the risk of bleeding associated with these treatments has been greatly under-appreciated," said Kim Fox, M.D., F.R.C.P., Director of Cardiology at Royal Brompton Hospital and Professor of Clinical Cardiology at Imperial College. "The gastrointestinal toxicity from dual antiplatelet therapy can result in patients skipping or stopping their treatment altogether," continued Dr. Fox. "Even a short discontinuation of therapy in patients who have recently had a drug eluting stent inserted can result in a heart attack. Clearly there is a need for a safer treatment option."
Recent clinical trial data documenting these side effects have begun focusing attention on the incidence and significance of bleeding associated with antiplatelet medicines.
"Our goal is to improve the safety and tolerability of antiplatelet therapy by significantly reducing gastrointestinal adverse events, including bleeding, to help patients stay on their intended antiplatelet treatment," said Mark A. Goldsmith, M.D., Ph.D., President and Chief Executive Officer of Cogentus Pharmaceuticals. "We believe CGT-2168 may be a significant advance that will preserve and extend the cardiovascular benefits of antiplatelet therapy."
Phase III trials are the last stage of clinical testing required by the U.S. Food and Drug Administration. Successful Phase III studies allow a company to file a New Drug Application with the FDA for approval to market a new medicine.