Ipsen announced that its partner Inspiration Biopharmaceuticals was notified by the FDA that both clinical trials evaluating the safety and efficacy of IB1001, an investigational intravenous recombinant factor IX, or rFIX, therapy for the treatment and prevention of bleeding episodes in people with hemophilia B, were placed on clinical hold. The clinical hold impacts two ongoing IB1001 clinical trials – a phase III study evaluating the safety and efficacy of IB1001 to treat and prevent bleeding episodes in adults with hemophilia B, and a phase III study evaluating the safety and efficacy of IB1001 to treat and prevent bleeding episodes in previously treated pediatric subjects with hemophilia B. During the course of routine laboratory evaluations conducted as part of the ongoing phase III clinical trials, Inspiration observed, and reported to the FDA, a trend towards a higher proportion of IB1001 treated individuals developing a positive response to testing of antibodies to Chinese Hamster Ovary, or CHO, protein, the product's host cell protein, or HCP. While this finding may be a potential safety concern, no evidence suggests a change in the current overall clinical benefit and risk profile of IB 1001.
- clinical trials