LFB SA initiates Phase 3 program for human Factor VIIa in patients with congenital hemophilia

LFB SA, through its rEVO Biologics subsidiary, announced today initiation of the global Phase 3 program for LR769, a novel recombinant form of human Factor VIIa, in patients with congenital hemophilia A or B with inhibitors.

LR769 was developed using rPRO™ technology and is being developed for treatment and prevention of bleeding episodes in hemophilia A and B patients with inhibitors to Factor VIII or IX.

The initial Phase 3 clinical trial is an open-label, multicenter study designed to evaluate the efficacy, safety and pharmacokinetics of LR769 in adolescent and adult hemophilia A and B patients with inhibitors. The study will evaluate two dosing regimens for the treatment of bleeding episodes. Initial results, expected in the second half of this year, will provide the basis for subsequent studies. The second study will assess the efficacy of LR769 for the treatment of bleeding episodes in pediatric hemophilia patients with inhibitors. The third study will evaluate the prevention of bleeding complications in patients undergoing surgery. Both are expected to start early 2015.

"This represents a major step toward LFB's goal of making a new recombinant Factor VIIa treatment available around the world for the treatment of hemophilia A and B patients with inhibitors to Factor VIII or IX," said Christian Béchon, Chairman and Chief Executive Officer, LFB S.A. "If proven safe and effective, LR769 would provide doctors with the first new therapeutic option in more than 15 years for these difficult to treat hemophilia patients. Our goal is to bring therapeutic choice and innovative medicines to these patients".