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news.Inspiration Biopharmaceuticals has initiated a Phase I clinical trial of IB1001, an intravenous recombinant Factor IX product for control and prevention of hemorrhagic episodes in patients with hemophilia B.
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The Phase I clinical trial is designed to assess the safety, tolerability and pharmacokinetics of IB1001 in patients with hemophilia B, compared with the commercially available recombinant Factor IX product.
Following the successful completion of this study, patients will then be followed for the six month Phase II/III trial either based on an on-demand or prophylaxis protocol.
Inspiration’s lead product candidate IB1001, has completed preclinical testing and is now entering clinical studies in the US and is poised to enter clinical testing in Europe and Israel.
John Taylor, chairman and co-founder of Inspiration Biopharmaceuticals, said: “The initiation of this Phase I trial is an important milestone for the company and for the hemophilia community. This is the first therapy for hemophilia B patients in the past two decades. We continue to develop a Factor product portfolio in both IV and non-invasive dosage forms for hemophilia and other coagulation disorders.”