Press release
Catalyst Biosciences Announces Pivotal Phase 3 Study Design for MarzAA in Individuals with Hemophilia A or B with Inhibitors
SOUTH SAN FRANCISCO, Calif., April 06, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO), a biopharmaceutical company that is developing
About this update from Gyre Therapeutics, Inc.
[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., April 06, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO), a biopharmaceutical company that is developing novel subcutaneous (SQ) therapies for hemophilia and other inherited bleeding disorders, today announced that it has received guidance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on a pivotal Phase 3 trial design for Marzeptacog alfa (activated) – MarzAA. The open-label trial will evaluate the efficacy of SQ MarzAA to treat episodic bleeding in individuals with hemophilia A or B with inhibitors.\n “Now that we have received regulatory feedback, we have initiated preparations for a Phase 3 trial of MarzAA in individuals with hemophilia A or B with inhibitors,” said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. “We plan to enroll the first patient before year end, however that date is dependant on the readiness of our trial sites and improvements in the current effects of COVID-19 on clinical trial execution. At present, manufacturing and drug supply are unaffected for our clinical trials.” The Phase 3 Crimson-1 (Subcutaneous Marzeptacog Alfa (Activated) For On demand Treatment and Control of Bleeding Episodes in Subjects with Hemophilia A or Hemophilia B with Inhibitors) study will enroll individuals who experience episodic bleeding. Crimson-1 will be an open-label global trial, evaluating the safety and efficacy of SQ MarzAA in the treatment of approximately 230 bleeding episodes in approximately 75 patients, compared with their prior standard of care in a similar number of bleeding episodes. The study will assess the effectiveness of SQ MarzAA, using up to 3 doses to treat a bleeding episode. The primary endpoint will be hemostatic efficacy using a standard 4-point assessment scale. About Marzeptacog alfa (activated) MarzAAMarzeptacog alfa (activated), or MarzAA, is a potent, subcutaneously (SQ) administered, next-generation recombinant Factor VIIa variant. Catalyst completed a Phase 2 open-label SQ prophylaxis trial of MarzAA which met the trial’s primary and all of the secondary endpoints in 2019. The Company’s preclinical and clinical data support MarzAA’s potential use for treatment of episodic bleeding episodes and supports further clinical testing for on-demand treatment of bleeds in individuals with ...