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news.Kai Pharmaceuticals, a drug discovery and development company, has initiated enrollment in the Phase IIb efficacy study of Kai-9803, the company's proprietary inhibitor of the delta protein kinase C pathway.
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The Phase IIb trial is designed to assess the effect of Kai-9803 on reducing myocardial injury in patients with ST segment elevation myocardial infarction (STEMI) who are undergoing percutaneous coronary intervention (PCI). The Phase IIb trial is being funded by Bristol-Myers Squibb Company under a global development and commercialization collaboration.
Kai’s Phase IIb study is a randomized, placebo-controlled, single-dose, parallel group, multinational trial that is expected to enroll 1,058 patients with STEMI undergoing PCI. Patients with STEMI will be assigned randomly to receive one of three doses of KAI-9803 or placebo by IV infusion prior to beginning PCI. The primary efficacy endpoint is infarct size and key secondary measures include assessments of microvascular perfusion and cardiac function, as well as safety.
Steven James, president and CEO of Kai, said: “The achievement of this milestone is the result of a productive and highly collaborative relationship with Bristol-Myers Squibb. The company is a great partner for us, and we are delighted by the progress of our joint program.”