Daiichi Sankyo & Lilly stall two prasugrel trials

PRLog (Press Release) – Nov 05, 2007 – Daiichi Sankyo and Eli Lilly and have suspended enrolment and administration of the oral antiplatelet agent, prasugrel, in two Phase II studies until protocol amendments can be agreed. The changes are being made in the light of preliminary results from pharmacokinetic analyses involving patients and healthy volunteers, indicating that a dose adjustment may be appropriate for certain subpopulations.

The two small pharmacodynamic clinical trials compare the levels of inhibition of platelet aggregation in patients with coronary artery disease taking prasugrel or Sanofi Aventis/Bristol-Myers Squibb’s Plavix (clopidogrel). Neither study has an efficacy endpoint; this is being addressed in a pivotal Phase III head-to-head clinical study - TRITON TIMI-38 – which has enrolled 13,614 patients in 30 countries.

Patient enrolment in the Phase II studies will resume as soon as additional analyses of pharmacokinetic and clinical data are completed, and the protocols are amended and approved by institutional review boards. “These amendments are strictly protocol-related and do not provide a basis for inferring overall outcomes of other prasugrel trials,” said Dr J Anthony Ware, Lilly cardiovascular platform leader for prasugrel.

Prasugrel, discovered by Daiichi Sankyo and Ube Industries, is being co-developed by Daiichi Sankyo and Lilly initially for use in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI).