Exhibit 99.1
Catalyst Biosciences Reports First Quarter 2019 Operating & Financial Results and
Provides a Corporate Update
Final MarzAA Phase 2 data to be presented at upcoming International Society for Thrombosis &
Hemostasis (ISTH) meeting in July 2019
MarzAA Orphan Drug Designation received from the European Commission
Initiated DalcA Phase 2b Trial for the Treatment of Hemophilia B
SOUTH SAN FRANCISCO, Calif. –May 2, 2019 – Catalyst Biosciences, Inc. (NASDAQ: CBIO), today announced its operating and financial results for the first quarter ended March 31, 2019 and provided a corporate update.
“We are pleased with the clinical progress this quarter and look forward to several clinical read outs from both our MarzAA and DalcA hemophilia programs during 2019,” said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. “The data continue to demonstrate that our therapies are safe, highly efficacious and provide clinically meaningful reductions in bleeding in hemophilia patients. We believe that subcutaneous delivery is the future for hemophilia treatments and that our candidates have the potential to disrupt the current $3.7 billion intravenous factor replacement market.”
Recent Milestones:
| • | | Marzeptacog alfa (activated) –MarzAA, Catalyst’s next-generation engineered subcutaneous (SQ) coagulation Factor VIIa (FVIIa) for individuals with hemophilia A or B with inhibitors: Completed enrollment and dosing for the Phase 2 open-label SQ efficacy trial. Reported data on seven subjects who completed dosing to date who had apre-dose mean annualized bleed rate (ABR) of 18.2 (range of12.2-26.7) that was reduced to 2.1 (>90% reduction); and five of the seven subjects had no bleeds for 50 days at the lowest MarzAA dose (30 µg/kg). The Company’s interim data indicates MarzAA is safe and well tolerated and had no anti-drug antibody development. |
MarzAA received orphan drug designation for the treatment of hemophilia B from the European Commission.
| • | | Dalcinonacog alfa –DalcA, Catalyst’s next-generation engineered SQ coagulation Factor IX (FIX) for individuals with hemophilia B: Initiated a Phase 2b trial for the treatment of hemophilia B. The open-label study will evaluate the ability of DalcA to maintain steady state FIX levels above 12%, the minimum factor level required to prevent spontaneous bleeds, in individuals with severe hemophilia B. The trial will enroll up to six subjects who will receive a single intravenous dose followed by daily SQ doses of DalcA for 28 days. |
| • | | CB2679d-GT – Factor IX Gene Therapy: Completedpre-clinicalproof-of-concept study of FIX Gene Therapy for the treatment of hemophilia B. Demonstrated3-fold superior clotting activity and a4-to-5-fold reduction in bleeding time in a hemophilia B mouse model using an AAV vector containing the CB 2679d gene construct compared with anAAV-Padua gene construct. |