Phase I Trial Launched for Extended Half-Life Factor VIII

Baxalta has begun a Phase I, first-inhuman clinical trial of BAX 826, a recombinant factor VIII (rFVIII) treatment for hemophilia A that uses proprietary polysialic acid (PSA) technology to extend its circulating half-life. The open-label, dose-finding study will evaluate the safety and pharmacokinetics of BAX 826 in 30 patients in three dosing cohorts, and plans to complete enrollment by the end of 2016.

BAX 826 is being studied as the company’s second extended half-life treatment based on Advate (antihemophilic factor [recombinant]). Baxalta has partnered with Xenetic Biosciences Inc. to develop novel forms of polysialyated blood coagulation factors, including FVIII, using Xenetic’s PolyXen biopolymer PSA technology to extend the circulating half-life and potentially improve the pharmacokinetic profile. Preclinical studies indicated BAX 826 offered an extended circulating half-life compared to standard rFVIII.