In February 2011, Inspiration Biopharmaceuticals, Inc., reported data on the pharmacokinetics (processing and duration of drug’s effect in the body) of IB1001, its recombinant factor IX (FIX) product for the treatment and prevention of bleeding in individuals with hemophilia B. The data were presented as a poster titled, “Pharmacokinetics of IB1001, a New Recombinant Factor IX,” at the 4th Annual Congress of the European Association for Haemophilia and Allied Disorders in Geneva, Switzerland, on February 2-4, 2011.
The randomized, double-blind study was conducted on 32 patients with severe hemophilia B. Results of the Phase 1 portion of an ongoing clinical study demonstrated noninferiority (that a new treatment is equivalent to standard treatment) of IB1001 in achieving overall levels of replacement factor when compared to Pfizer’s BeneFIX®, the only approved recombinant FIX product for hemophilia B.
“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,” said Ed Gomperts, MD, Medical Director of Inspiration Biopharmaceuticals. “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.”
IB1001 is now in a Phase 3 trial, which should yield safety and efficacy results later this year.
Source: Inspiration press release dated February 3, 2011
