Bayer has started to enroll patients in an international Phase II/III trial to evaluate a new treatment for haemophilia A.
The PROTECT VIII study 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, "while also having the ability to treat acute bleeding events", the German drugmaker said. The trial will enroll 120 to 140 previously-treated subjects worldwide.
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, Bayer noted. The company is already a leading player in haemophilia with Kogenate (recombinant antihaemophilic factor), which enjoyed first-quarter sales of 295 million euros.
Kemal Malik, head of global development at Bayer Healthcare, noted that the firm has "more than 20 years of research and clinical experience in haemophilia. He added that "a longer-acting rFVIII product may result in significant benefit in long-term outcomes and quality of life improvements for people with haemophilia A".