Ipsen's (IPSEF.PK) partner, Inspiration Biopharmaceuticals Inc., was notified by the Food and Drug Administration or FDA that both studies evaluating the safety and efficacy of IB1001, an investigational intravenous recombinant factor IX (rFIX) therapy for the treatment and prevention of bleeding episodes in people with hemophilia B, were placed on clinical hold.
The clinical hold impacts 2 ongoing IB1001 clinical trials such as 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 IB1001 to treat and prevent bleeding episodes in previously treated pediatric subjects with hemophilia B.
The adult study has completed its primary analysis period. Following the FDA's request, Inspiration has notified clinical sites in the U.S. to hold treatment of patients with IB1001. Also, Inspiration Biopharmaceuticals is sharing the FDA directive with regulators in countries outside of the U.S. where the studies are being conducted.
Totally, 86 people with hemophilia B have received IB1001 in trials and, to date, no adverse events related to the development of antibodies to CHO protein have been reported. Moreover, no relationship has been showed between the development of antibodies to CHO protein and the development of any antibodies to factor IX, the company added.
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