Cogentus's Clinical Study To Confirm Full Antiplatelet Benefit Of New Combination Medicine

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Cogentus Pharmaceuticals has begun dosing in a clinical study to confirm the full antiplatelet activity of its novel combination medicine CGT-2168. CGT-2168 is a once-daily capsule that combines clopidogrel (currently marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis as Plavix) with a gastroprotectant (omeprazole) to improve the gastrointestinal safety of antiplatelet therapy.

The crossover study (CG106) will characterize the pharmacodynamic effects of CGT-2168 compared with Plavix and will expand earlier findings of comparability. "In a previous clinical trial we demonstrated that the absorption of CGT-2168 is equivalent to that of Plavix, and that the omeprazole component within CGT-2168 does not interfere with the metabolism of the clopidogrel component," said Cogentus Chairman and Chief Executive Officer Mark A. Goldsmith, M.D., Ph.D.

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An independent study published this week in the Journal of the American College of Cardiology showed that commercially available omeprazole significantly decreases the antiplatelet activity of Plavix when the two medicines are co-administered. "This finding is consistent with our own earlier clinical data that revealed an adverse drug interaction between Plavix and Prilosec (marketed omeprazole), and may raise serious concerns for patients and practitioners," Dr. Goldsmith said. "However, these findings contrast with the properties we have observed with our unique formulation, CGT-2168. We expect the CG106 trial to confirm that CGT-2168 exhibits full antiplatelet activity and avoids the drug-drug interaction reported with the individual drugs on the market today."

Separately, Cogentus has begun COGENT-1, a global Phase 3 trial that will evaluate the clinical benefits of CGT-2168 with aspirin compared to Plavix with aspirin. COGENT stands for the Clopidogrel and the Optimization of Gastrointestinal Events Trial.

While antiplatelet therapy has been shown to be effective in preventing major cardiovascular events, it is associated with significant gastrointestinal side effects including bleeding, which can interrupt treatment, may require hospitalization or in some cases even result in death. A study recently published in the Annals of Internal Medicines concluded that the antiplatelet drugs aspirin and clopidogrel are, respectively, the third and fourth most common causes of U.S. emergency room visits by older adults experiencing adverse drug events.

"Because of potentially important safety and efficacy concerns surrounding antiplatelet therapy, Cogentus is investing significantly in completing the testing of our next-generation medicine that may provide patients and physicians with a treatment option that preserves the full cardiovascular benefits while minimizing potentially dangerous side effects," Dr. Goldsmith said.

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