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 in children. The PROTECT VIII (PROphylaxis in hemophilia A patienTs via directly pEgylated long-aCTing rFVIII) Kids trial is designed to determine the effects of BAY94-9027, a recombinant human factor VIII (rFVIII), when used as prophylaxis, dosed at least once weekly and as on-demand for acute bleeding events.
BAY94-9027 has been designed to extend the circulating half-life of rFVIII through site specific attachment of a polyethylene glycol (PEG) polymer to the light chain of the rFVIII molecule, while preserving its full biologic activity.
"We are happy that prophylaxis with this long-acting compound is now being studied in children younger than twelve years of age to complement our ongoing adult study. We look forward to sharing clinical trial results on BAY94-9027 when they are available," said Dr. Georg Lemm, Vice President, Global Clinical Development Hematology, Bayer HealthCare.
Bayer is committed to developing treatment solutions that meet the needs of the hemophilia community. Whether through research, support or clinical management, Bayer is dedicated to helping persons with hemophilia and their families.