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news.Biovitrum and Syntonix Pharmaceuticals have obtained FDA approval to start a clinical Phase I/IIa study of a intravenous, long-acting, recombinant Factor IXFc or (FIXFc) in previously treated hemophilia B patients.
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This first in human study aims to evaluate the safety and tolerability of FIXFc together with its pharmacokinetic profile (primarily its plasma half-life) after a single injection of six different doses. The study will be performed at two clinics in the US.
Martin Nicklasson, CEO of Biovitrum, said: “We are excited to develop FIXFc with Syntonix because we believe that the company’s SynFusion technology has resulted in a very promising, long-acting recombinant Factor IX product opportunity that has the potential to reduce the frequency of infusions required for hemophilia B patients to manage their disease.”