Inspiration Biopharmaceuticals Announces Data from OBI-1 Pivotal-Stage Program in Hemophilia at 23rd ISTH Congress
KYOTO, Japan, July 28, 2011 /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc. (Inspiration) today announced data from its clinical development program for OBI-1, an intravenous (IV) recombinant porcine factor VIII product (rpFVIII), intended for the treatment of bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia. The data were presented in a Scientific Session held in conjunction with the 23rd Congress of the International Society on Thrombosis and Haemostasis (ISTH), which was chaired by Amy Shapiro, M.D., Co-Medical Director at the Indiana Hemophilia and Thrombosis Center (IHTC).
During the Scientific Session, Anne Greist, M.D., Co-Medical Director at IHTC, presented interim results from the first registration study in the OBI-1 Accur8 clinical trial program. A total of three patients with acquired hemophilia, who had experienced severe bleeds not controlled with by-passing agents, were treated with OBI-1; in all three patients, treatment with OBI-1 stopped the bleeding. Further data on hemostatic efficacy and safety are being collected as part of the Accur8 clinical trial program, designed to study OBI-1 in acquired hemophilia. A second study in individuals with congenital hemophilia A who have developed inhibitors against FVIII is set to commence later this year.
Additional reports from the Scientific Session confirmed findings from the Phase 2 study in congenital hemophilia A with inhibitors; that OBI-1 effectively resulted in hemostasis, and controlled all non-life/non-limb threatening bleeding episodes in individuals with congenital hemophilia A and inhibitors, even in the presence of high inhibitor levels. All 25 bleeds in the study were controlled, and twenty out of 25 bleeds (80%) were controlled with two infusions. In over 40 infusions administered, OBI-1 was well tolerated by all participants and no drug-related serious adverse events were observed.