The Phase I trial is a prospective open-label study, designed to demonstrate the safety, tolerability and pharmacokinetics of BAX 855 in previously-treated patients aged 12 years or older with severe hemophilia A.
BAX 855 leverages the company’s Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method (ADVATE) full-length rFVIII molecule and plasma/albumin-free (PAF) manufacturing process.
The drug candidate uses Nektar Therapeutics’ proprietary PEGylation technology, which will extend the duration of activity of proteins and larger molecules.
Earlier Phase IV prophylaxis study showed that ADVATE for routine prophylaxis significantly reduced median annual bleed rates (ABRA) in hemophilia A patients.
Baxter Bioscience business global research and development vice president Hartman Ehrlich said the Phase I results will form the basis to advance the clinical development program of BAX 855, and will offer new insights about their investigations longer-acting FIFI molecule.