Inspiration presents IB1001 PK data for treatment of hemophilia B

Feb 3 2011

Inspiration Biopharmaceuticals, Inc. (Inspiration) today presented pharmacokinetic (PK) data on its lead product, IB1001, a recombinant factor IX (FIX) for the treatment and prevention of bleeding in individuals with hemophilia B.  Results of the Phase 1 portion of an ongoing IB1001 clinical study demonstrated non-inferiority of IB1001 in achieving overall levels of replacement factor compared to BeneFIX®, the only approved recombinant FIX product for the treatment of hemophilia B.  Currently, IB1001 is in Phase 3, with safety and efficacy results expected later this year.

The clinical results were presented at the 4th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) in Geneva, Switzerland, in a poster presentation titled, "Pharmacokinetics of IB1001, a New Recombinant Factor IX".

Ed Gomperts, M.D., Medical Director of Inspiration Biopharmaceuticals, commented, "We are very encouraged by the clinical results for IB1001, which showed PK results at least as good as the existing, marketed recombinant FIX product.  Further, the findings were similar in terms of half-life and in vivo recovery, which is fundamental for the determination of dose for the prevention and treatment of spontaneous bleeds, as well as trauma associated with surgical procedures."

Dr. Gomperts continued, "There remains a large gap in hemophilia treatment, with access to care primarily limited by availability and cost of therapy.  New initiatives are greatly needed globally.  Pending approval, a new recombinant FIX product such as IB1001 will increase product availability and thus should improve access to care, including prophylactic therapy of hemophilia B in a market where recombinant FIX is limited to only one approved product."

"We are pleased with the continued progress of the IB1001 program," stated Michael Griffith, Ph.D., President and CEO of Inspiration.  "In the past 12 months, Inspiration has made great strides in product development for the treatment of hemophilia, including the initiation of pivotal testing in its two lead programs.  In addition to IB1001, we are developing OBI-1, a recombinant porcine factor VIII (FVIII) for individuals who have developed inhibitors against human FVIII and for those with acquired hemophilia A.  OBI-1 specifically addresses the unmet medical need in inhibitor therapy for individuals with hemophilia."

The randomized, double-blind, cross-over PK protocol was designed to show non-inferiority of IB1001 compared to the only marketed recombinant FIX product.  The study enrolled 32 individuals with severe hemophilia B.  Individuals in the study were infused with either IB1001 or the comparator, and their FIX levels were assessed at different time intervals.  After a predetermined time period, individuals received the second product and FIX levels were assessed at the same time points.