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Inspiration Biopharmaceuticals Treats First Patient in Pivotal Study of OBI-1 for Acquired Hemophilia A
Date:11/19/2010

al hemophilia, acquired hemophilia is typically a disorder of older adults, and occurs equally in both males and females.  Also, the pattern of bleeding seen in acquired hemophilia is different from that observed in the more common congenital form.  In acquired hemophilia, individuals typically bleed into the skin, muscles and soft tissues, as opposed to bleeding into joints, which is more typical in congenital hemophilia.

About OBI-1

Approximately one-third of individuals with hemophilia A develop an immune reaction (inhibitors) to human FVIII (hFVIII) and can no longer respond to treatment with the coagulation factor.  Current therapies, specifically human factor VIIa (NovoSeven®) and FEIBA, work by bypassing the natural hemostatic pathway and forcing coagulation with much higher levels of FVIIa than normal.  In contrast, OBI-1, a recombinant form of porcine FVIII that typically possesses low cross reactivity to anti-hFVIII antibodies, is a replacement therapy, activating the natural hemostatic pathway.  This should allow clinicians to correlate activity and efficacy with a biomarker, and therefore guide dosing to better predict treatment outcomes.  OBI-1 presents a unique and alternative approach to address the needs of individuals who have developed inhibitors to hFVIII and is highly desired by the medical community.

OBI-1 has been evaluated in a Phase 2 study in patients with congenital hemophilia A who have developed inhibitors to hFVIII, and who presented with a non-life/non-limb threatening bleed.  The Phase 2 study demonstrated OBI-1 was well-tolerated and can be given over a short infusion time.  In addition to the recently initiated pivotal trial of OBI-1 in individuals with acquired hemophilia A, Inspiration is planning a separate pivotal trial in individuals with congenital hemophilia A who have developed inhibitors against hFVIII.

About Inspiration Biopharmaceuticals
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SOURCE Inspiration Biopharmaceuticals, Inc.
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