Biovitrum and Syntonix begin phase I/IIa clinical trial of long-acting recombinant Factor IXFc for treatment of Hemophilia B
Biovitrum AB and Syntonix Pharmaceuticals, Inc. have obtained approval from the US food and Drug Administration to commence a clinical phase I/IIa study of a long-acting, recombinant Factor IXFc for the treatment of hemophilia B.
The US Food and Drug Administration (FDA) has approved the initiation of a phase I/IIa safety and pharmacokinetic study of intravenous, long-acting, recombinant Factor IX (FIXFc) in previously treated hemophilia B patients. 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 United States.
There is an increasing trend toward use of Factor IX for prophylaxis treatment of Hemophilia B, which requires several infusions per week with the currently available drugs. The extended half-life of this new FIXFc product could enable effective treatment for both prophylaxis and on-demand therapy with less frequent intravenous injections and thereby provide a new, improved therapy for the patients. The total market potential for Factor IX products is estimated to be in excess of USD 600 million worldwide, per year.
"Hemophilia is a prioritized therapeutic and business area within Biovitrum. We are excited to develop FIXFc with Syntonix because we believe that the company's' SynFusionTM 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. The program fits well with Biovitrum's long experience and broad knowledge within the area of protein therapeutics and matches perfectly our focus on specialist indications." said Martin Nicklasson, CEO of Biovitrum..
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