FDA halts trials of IB 1001 (Inspiration Pharmaceuticals) for Haemophilia B - 11-Jul-2012

The FDA has placed a hold on clinical trials evaluating the safety and efficacy of IB 1001, an intravenous recombinant factor IX (rFIX), from Inspiration Pharmaceuticals, being investigated for the treatment and prevention of bleeding episodes in people with Haemophilia B. Trials have shown a higher proportion of individuals treated with IB 1001 have developed antibodies to proteins from the Chinese hamster ovary, or CHO, host cells used to manufacture the therapy than was expected based on earlier study data. Inspiration has notified clinical sites in the US to hold treatment of patients with IB 1001. Inspiration is also sharing the FDA directive with regulators in countries outside of the US where the studies are being conducted. This impacts two ongoing trials – a Phase III study evaluating the safety and efficacy of IB1001 to treat and prevent bleeding episodes in adults with Haemophilia B, and a Phase III/IIIb study evaluating the safety and efficacy of IB 1001 to treat and prevent bleeding episodes in previously treated pediatric subjects with Haemophilia B.