Amunix Operating has announced that the U.S. Food and Drug Administration (FDA) has accepted Bioverativ’s Investigational New Drug (IND) application for BIVV001 (also known as rFVIII Fc-VWF-XTEN) a novel, investigational Factor VIII therapy designed to potentially extend protection from bleeding episodes via prophylactic once-weekly dosing or longer for patients with hemophilia A.
BIVV001 is the only investigational Factor VIII therapy in development that has been designed to overcome the von Willebrand factor ceiling, which is believed to impose a half-life limitation on current Factor VIII therapies.
“We are very pleased by the announcement from Bioverativ that clinical enrollment is planned to begin in the latter half of 2017. This represents the second clinical trial involving an XTEN-based product to be initiated this year,” remarked Volker Schellenberger, CEO and President of Amunix. “We look forward to the evaluation of BIVV001 in the clinic and the continued progression of Bioverativ’s hemophilia programs that exploit the advantages offered by the XTEN technology platform.”