Catalyst Biosciences’ (NASDAQ:CBIO) activated marzeptacog alfa, or MarzAA, received FDA fast track designation for the treatment of episodic bleeding in subjects with hemophilia A or B who have developed coagulation factor inhibitors.
MarzAA is a subcutaneously administered, engineered coagulation Factor VIIa that is set to enter Catalyst’s Phase 3 CRIMSON 1 trial this month.
The study will enroll some 60 subjects to treat 244 eligible bleeding episodes with each treatment. The trial’s primary endpoint is the percentage of treated bleeds resulting in effective hemostasis at the 24-hour timepoint. The trial aims to demonstrate non-inferiority of MarzAA, compared with the standard-of-care.
“We believe the FDA fast track designation validates MarzAA’s potential to improve patient care,” Nassim Usman, Ph.D., Catalyst’s president and CEO, said in a statement.
“As the only subcutaneously delivered therapy in development for on-demand treatment of bleeding events, MarzAA is uniquely positioned to become an important addition to the treatment landscape,” he added.
