Search form

Inspiration Presents Data on Recombinant FVIII Product

PrintFriendly

Printer Friendly and PDF

Inspiration Presents Data on Recombinant FVIII Product

August 1, 2011

Inspiration Biopharmaceuticals, Inc. (Inspiration) recently presented data from its clinical development program for OBI-1, an intravenous recombinant porcine (pig) factor VIII product (rpFVIII). In January 2010, Inspiration and the pharmaceutical company Ipsen entered into a partnership to combine their expertise and technologies to develop new recombinant factor products. Under the terms of the agreement, Inspiration “in-licensed” OBI-1 from Ipsen, and is responsible for the clinical development, regulatory approval and commercialization of the product.

The data were presented at a Scientific Session held in conjunction with the 23rd Congress of the International Society on Thrombosis and Haemostasis, held in Kyoto, Japan, on July 23-29, 2011. The session was chaired by Amy Shapiro, MD, Co-Medical Director at the Indiana Hemophilia & Thrombosis Center (IHTC) in Indianapolis.

rpFVIII is intended for the treatment of bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia. Inhibitors are antibodies that develop in approximately 25% of patients. They neutralize the infused factor product. Acquired hemophilia is a rare, life-threatening condition that occurs in adults who develop inhibitors to clotting factor. Bleeds typically occur in the skin, muscles and soft tissue, rather than the joints.

Anne Greist, MD, Co-Medical Director at IHTC, presented interim results from the first registration study in the OBI-1 Accur8 clinical trial program. Three patients with acquired hemophilia, who had experienced severe bleeds not controlled with bypassing agents, were treated with OBI-1. The drug successfully stopped their bleeds. Additional study data on hemostatic efficacy (the ability to stop bleeding) and safety are being collected as part of the Accur8 program.

A Phase 2 study of patients with hemophilia and inhibitors showed that the treatment controlled their bleeding, even in those with high titers. All 25 bleeds were controlled, 80% of which required two infusions.

“OBI-1 represents a potential alternative treatment, which allows established laboratory parameters to guide dosing and monitor efficacy, in addition to clinical outcome. I am happy to report the progress that has been seen in this development program,” explained Greist during the session.

 

Source: Reuters, July 28, 2011