Bayer commences enrollment in BAY94-9027 Phase II/III trial for hemophilia A

Bayer HealthCare today announced the company has started to enroll patients in an international Phase II/III trial to evaluate its investigational compound BAY94-9027 for the treatment of hemophilia A. The PROTECT VIII (PROphylaxis in hemophilia A patienTs via directly pEgylated long-aCTing rFVIII) trial is designed to investigate whether BAY94-9027, a recombinant human factor VIII (rFVIII), can prolong the duration of protection from bleeds and allow for less frequent Infusions when used prophylactically, while also having the ability to treat acute bleeding events.

BAY94-9027 has been engineered to extend the half-life of rFVIII while preserving biologic activity by inserting a single cysteine (amino acid) site to its surface, which serves as an attachment site for a polyethylene glycol (PEG) polymer.

"Bayer continues to invest in research that may provide innovative ways to advance patient care," said Pamela Cyrus, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "This study is designed to determine the effects of a long-acting rFVIII product in people with hemophilia A."