Exhibit 99.1
Catalyst Biosciences Reports Fourth Quarter and Full-Year 2018 Operating &
Financial Results and Provides a Corporate Update
Completed enrollment of the MarzAA SQ Phase 2 trial and demonstrated safety and clinical
efficacy, with >90% reduction in bleeding
Completed a full immunogenicity analysis for DalcA, plan to initiate a
Phase 2b28-day SQ trial in March 2019
SOUTH SAN FRANCISCO, Calif. – Mar. 7, 2019 – Catalyst Biosciences, Inc. (NASDAQ: CBIO), today announced its operating and financial results for the fourth quarter and full-year ending December 31, 2018 and provided a corporate update.
“2019 will be a very exciting year for Catalyst with several clinical and regulatory read outs expected throughout the year,” said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. “Both Phase 2 trials demonstrate that our therapies are clinically efficacious when dosed subcutaneously, which we believe is the future for hemophilia treatments. Subcutaneous MarzAA and DalcA have the potential to be disruptive to current intravenous products, an approximately $3.4 billion market, and they are especially well-suited for children.”
Recent Milestones:
| • | | Marzeptacogalfa (activated) –MarzAA, subcutaneously administered next-generation engineered coagulation Factor VIIa: Completed enrollment of 11 individuals, with hemophilia and an inhibitor in a Phase 2 efficacy trial. The trial is evaluating the ability of MarzAA to eliminate, or minimize, spontaneous bleeding episodes in individuals with hemophilia A or B with an inhibitor. As of February 2019, seven of 11 subjects had completed dosing with a reduction in annual bleed rates (ABR) from 18.2 to 2.1 (>90% reduction) and five of the seven had no bleeds for 50 days at their final dose. The Company’s interim data indicates MarzAA is safe and well tolerated. Subcutaneous half-life increased to 13.1 hours compared with intravenous half-life of 3.9 hours. |
| • | | Dalcinonacog alfa – DalcA, subcutaneously administered next-generation engineered coagulation Factor IX: Completed a Phase 1/2 subcutaneous dosing trial. The trial evaluated the safety and efficacy of DalcA in individuals with severe hemophilia B. Data from the study demonstrated that DalcA is highly efficacious, achieving activity levels well above that required for prevention of spontaneous bleeding. Two subjects developed neutralizing antibodies, one transiently, that did not interfere with their ability for continued use of other FIX products. The Company completed a full investigation and concluded that DalcA has a similar low immunogenicity potential as do BeneFIX and other commercial wildtype Factor IX products. The Company is moving forward in clinical development of DalcA and will start a Phase 2b trial in March 2019, enrolling up to six patients each with 28 days of dosing. |