Baxalta Commences Phase 1 Clinical Trial Of BAX 826 - Quick Facts

(RTTNews) - Baxalta Inc. (BXLT) said it has dosed the first patient in its Phase 1, first-in-human clinical trial of BAX 826, a recombinant Factor VIII or rFVIII treatment for hemophilia A that uses proprietary polysialic acid (PSA) technology to extend its circulating half-life.

BAX 826 is under investigation as Baxalta's second extended half-life treatment based on ADVATE, or Antihemophilic Factor (Recombinant), the world's most prescribed FVIII treatment.

The open-label, dose-finding study evaluating the safety and pharmacokinetics of BAX 826 plans to enroll 30 patients in three dosing cohorts. Baxalta expects to complete enrollment by the end of 2016.

"This is an important step in evolving extended half-life treatments as we aim to improve bleed protection for hemophilia A patients while potentially offering once-weekly dosing," said John Orloff, head of Research & Development and chief scientific officer, Baxalta.

Baxalta also continues to drive hemophilia innovation with the development of new advances like gene therapy.