Biovitrum AB and Syntonix Pharmaceuticals, Inc. announced the start of a phase I/IIa open-label, dose escalation study of a long-acting, recombinant factor IX (FIXFc) therapy in patients with hemophilia B. The purpose of this clinical study is to assess the safety, tolerability and pharmacokinetics of FIXFc.
The new trial, which is ongoing at clinics in the U.S., follows pre-clinical studies demonstrating that FIXFc could have an extended half-life. This means hemophilia B patients will have the convenience of less frequent infusions for both on-demand and prophylactic treatment regimens. Syntonix’s technologies employ therapeutic proteins, peptides and antibodies to help create longer-acting biopharmaceutical therapies to treat chronic disorders such as anemia, multiple sclerosis and autoimmune disorders. Biovitrum develops and manufactures protein-based therapies for common diseases and those affecting smaller populations.
“We are excited about developing FIXFc together with Syntonix since hemophilia is a prioritized therapeutic and business area within Biovitrum,” said Martin Nicklasson, CEO of Biovitrum. “In addition, we are developing a recombinant Factor VIIIFc hemophilia product with Syntonix.”
Biovitrum has headquarters in Sweden and the United Kingdom. Syntonix, a wholly-owned subsidiary of Biogen Idec, is based in Waltham, MA. The two companies first entered into a co-development and commercialization alliance to develop FIXFc in January 2006.
Source: Biovitrum press release dated May 27, 2008