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news.Portola Pharmaceuticals, a biopharmaceutical company, has announced new clinical data that demonstrate PRT060128, the company's novel anti-platelet drug that directly and reversibly inhibits the P2Y12 ADP receptor, overcomes high platelet reactivity in patients who do not respond to clopidogrel.
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In this study, 20 patients were identified with stable coronary artery disease that were treated with chronic clopidogrel (75mg) and aspirin therapy and have high platelet reactivity (HPR). These clopidogrel non-responders were treated with one oral dose of PRT060128 (60mg) at 12 to 16 hours after the previous day’s dose of clopidogrel. Platelet aggregation was determined by ADP and collagen-induced aggregation and pharmacodynamic assays.
According to the company, the mean platelet reactivity was reduced from the highest (non-responder) to lowest (normal responder) tertile, following dosing with PRT060128, and achieved the predefined endpoint. Inhibition of thrombosis was highly significant in these non-responder patients. The oral dose of PRT060128 chosen for this study is at the low end of the dosing range that will be evaluated in the Portola’s upcoming Phase II study.
Portola believes that PRT060128 may provide significant clinical benefit through immediate, high-level platelet inhibition in the acute setting and a seamless transition to predictable, reversible platelet inhibition in the chronic setting.
Charles Homcy, president and CEO of Portola, said: “We are encouraged by these clinical results suggesting PRT060128 may be effective and well tolerated in clopidogrel non-responders. This novel agent has immediate, predictable and reversible platelet inhibition that appears to overcome HPR in non-responders and other major limitations of clopidogrel.”