Press release
Catalyst Biosciences Reports First Quarter 2020 Operating & Financial Results and Provides a Corporate Update
MarzAA Phase 3 study first patient enrollment targeted before year end following FDA and EMA regulatory feedback DalcA Phase 2b study completed, final data to
About this update from Gyre Therapeutics, Inc.
[{"type":"text","content":"MarzAA Phase 3 study first patient enrollment targeted before year end following FDA and EMA regulatory feedback\n DalcA Phase 2b study completed, final data to be presented in the second quarter SOUTH SAN FRANCISCO, Calif., May 11, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced its operating and financial results for the first quarter ended March 31, 2020 and provided a corporate update. “Despite disruptions in clinical and preclinical research operations affecting the biotechnology industry as the result of the COVID-19 pandemic, we have continued to make significant progress in both our MarzAA and DalcA programs,” said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. “We have incorporated guidance from FDA and EMA in our Phase 3 trial design for MarzAA and anticipate enrolling the first patient before the end of the year. We completed our Phase 2b DalcA study and will present the final data before the end of the quarter.” Dr. Usman continued, “As we look forward, our solid financial position and progress across our portfolio give us confidence in our ability to advance our programs through several important milestones. I would like to thank our study participants, collaborators, contractors and employees for their dedication and flexibility that has allowed us to advance the development of our new medicines as we face these trying times together.” Recent Milestones: Marzeptacog alfa (activated) – MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa): The Company received guidance from the FDA and the EMA on a pivotal Phase 3 trial design for 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. Dalcinonacog alfa – DalcA, a subcutaneously administered next-generation engineered coagulation Factor IX (FIX): The open-label Phase 2b study was designed to evaluate the ability of DalcA to maintain steady state protective FIX levels above 12% in six individuals with severe hemophilia B. Each subject received a single intravenous dose, followed by daily SQ doses of DalcA for 28 days. Data presented at the European Association for Haemophilia and Allied Disorders (EAHAD) Congress in February showed that daily SQ dosing of DalcA achiev...