Phase 2/3 Study Update of OBI-1 for Acquired Hemophilia A
Inspiration Biopharmaceuticals reported data from its ongoing Phase 2/3 study evaluating the efficacy of OBI-1 for the treatment of serious bleeds in people with acquired hemophilia A.
The Accur8 Auto-antibody trial is an ongoing prospective, open label study. The primary objective of the study is to evaluate the efficacy of OBI-1 treatment for serious (life- or limb-threatening) bleeds in individuals aged ≥18 with acquired hemophilia A, as measured by the control of bleeding 24 hours after initial OBI-1 dose administration. The interim analysis included data from the first seven trial participants with severe bleeds not controlled with bypassing agents who were enrolled and treated with OBI-1. To date, 15 subjects have been enrolled and completed treatment in the clinical trial. Participants received 200U/kg of OBI-1 on first injection and were subsequently dosed based on target factor VIII levels. All seven subjects experienced successful control of bleeds at 24 hours and subsequent resolution of their bleeds. Therapeutic factor VIII activity levels were achieved and maintained with intermittent OBI-1 administration based on factor VIII levels.
OBI-1 is an investigational recombinant porcine factor VIII.
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