Ipsen announced that its partner Inspiration Biopharmaceuticals, Inc. has initiated the treatment of the first patient in the second of two Phase 3 studies from the OBI-1’s Accur8 clinical trial program. In this newly initiated clinical study, OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product, will be evaluated for the treatment of individuals with congenital hemophilia A, who have developed inhibitory antibodies (inhibitors) against their human FVIII replacement therapy.
Under the partnership agreement signed with Inspiration in January 2010, the initiation of this clinical study triggers the subscription by Ipsen to a $25 million convertible note newly issued by Inspiration. Ipsen’s fully diluted share ownership position in Inspiration now reaches about 40.7%.
Marc de Garidel, Chairman and Chief Executive Officer of Ipsen said: “The initiation of the second OBI-1 Phase 3 clinical trial in congenital hemophilia A with inhibitors is an important step forward in the development of our hemophilia franchise. Currently, patients suffering from hemophilia A who have developed inhibitors have limited therapeutic options. The advancement of OBI-1 clinical program paves the way towards potential major improvements in the therapeutic armamentarium within the coming years. We are pleased with the progress made by Inspiration who initiates in due time the second OBI-1 Phase 3 clinical trial after having filed a Marketing Authorization Application in Europe for IB1001, a recombinant factor IX.”
The OBI-1 Phase 3 clinical study is a prospective, non-randomized, open-label study evaluating the efficacy of OBI-1 for the treatment of serious bleeding episodes, including episodes that are a threat to a patient’s life or vital organs. The first patient is being treated at the Johannesburg Hospital in South Africa.
Date: November 28, 2011