Last month, Inspiration Biopharmaceuticals, Inc., announced that it had initiated treatment of patients in a phase II/III clinical study of OBI-1, an intravenous recombinant porcine (pig) factor VIII product. The purpose of the study is to test whether OBI-1 is safe and effective for the treatment of serious bleeding episodes in individuals with acquired hemophilia A.
Acquired hemophilia A 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.
In January 2010, Inspiration and another 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.
Approximately 1/3 of patients with congenital hemophilia A develop inhibitors. According to the company’s press release, OBI-1 is a unique alternative to treating inhibitors with bypassing agents, such as factor VII products. In a phase 2 study of patients with hemophilia A and inhibitors, OBI-1 was well tolerated and had a shortened infusion time.
“Acquired hemophilia is a condition in which patients develop antibodies against their own coagulation factors. Affecting men and women equally, acquired hemophilia can lead to a life-threatening crisis for patients,” said Anne Greist, MD, at the Indiana Hemophilia & Thrombosis Center in Indianapolis. “Unfortunately, current therapies are often inadequate to stop these types of acute bleeding episodes, and new innovative therapeutic approaches are needed. We are pleased to have been the first site in the U.S. to enroll a patient in the pivotal study of OBI-1, a promising and important new product candidate in the treatment of acquired hemophilia.”
Source: PR Newswire, November 19, 2010