Catalyst Updates Positive Interim Data from Phase 2/3 Hemophilia Study

Results demonstrate efficacy of subcutaneous prophylaxis with MarzAA, Catalyst’s high potency engineered FVIIa

Data presented at 60^th American Society of Hematology Annual Meeting & Exposition

Catalyst Biosciences, Inc. (NASDAQ: CBIO), a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, today announced additional positive interim data from its Phase 2/3 study of subcutaneous prophylactic Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA), currently being developed for the treatment of hemophilia A or B with inhibitors. The data were presented in a poster at the 60^th American Society of Hematology (ASH) Annual Meeting & Exposition on December 1, 2018 in San Diego.

“These results support the efficacy of MarzAA as a subcutaneous prophylactic treatment option for individuals with hemophilia A or B with inhibitors,” said Nassim Usman, Ph.D., chief executive officer of Catalyst. “We observed that bleeding in individuals with high annualized bleed rates is significantly reduced or eliminated during MarzAA treatment. With these new data from two additional individuals who have successfully completed the trial, we are optimistic about the potential for MarzAA treatment to achieve extremely low annualized spontaneous bleed rates with individualized, subcutaneous daily dosing.”

Dr. Howard Levy, chief medical officer of Catalyst, presented the updated results, including the new data from two additional subjects who have completed the Phase 2/3 MarzAA trial. The first subject, who had an annualized bleed rate (ABR) of 15.2, had no bleeds during 50 days of treatment with 30 µg/kg MarzAA. The second subject, who had an ABR of 22.2, experienced a bleed on Day 4 that did not require treatment. The subject continued on the 30 µg/kg dose level, as the bleed occurred within the first five days of dosing when FVIIa levels are still increasing to therapeutic levels and completed the trial with no additional bleeds during the treatment period.

https://www.marketscreener.com/CATALYST-BIOSCIENCES-INC-34019199/news/Catalyst-Biosciences-Announces-Updated-Positive-Interim-Data-from-Its-Phase-2-3-Study-of-Marzeptacog-27692962/