Diamyd Medical AB announced that it has suspended and is initiating the closure of its U.S. Phase 3 study, DiaPrevent, which was evaluating the use of Diamyd for the treatment of newly diagnosed type 1 diabetes. Diamyd, in consultation with the FDA, has decided to suspend dosing following a blinded review of the efficacy data from the study collected to date and the previously reported negative outcome of a European Phase 3 study of the same design. Acting President and CEO of Diamyd Medical, Peter Zerhouni, said that their review of the available data suggests the study is not likely to reach a positive outcome regarding efficacy and therefore it cannot be justified to complete the study as originally planned.
Diamyd’s active substance is a human protein GAD65 (Glutamic acid decarboxylase isoform 65 kDa) and is an investigational antigen-based diabetes therapy.
For more information call (412) 488-0348 or visit www.diamyd.com.