Catalyst Biosciences, Inc. (Nasdaq:CBIO), today announced the initiation of enrollment in a Phase 2b study of dalcinonacog alfa (DalcA), a next-generation subcutaneously (SQ) administered Factor IX (FIX) therapy being developed for the treatment of hemophilia B.
The data from our Phase 1/2 clinical study demonstrated that DalcA is highly efficacious for the treatment of hemophilia B and can achieve Factor IX activity levels well above the 12% expected to prevent spontaneous bleeding, said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. We anticipate that this Phase 2b study will further demonstrate DalcAs safety and efficacy as a subcutaneous prophylactic treatment option. Individuals with severe hemophilia B face a lifetime of complicated intravenous treatment regimens. We believe that DalcA may offer a conveniently-dosed subcutaneous prophylactic treatment option that could significantly improve the quality of life for those suffering from severe hemophilia B.
The open-label Phase 2b study will evaluate the ability of DalcA to maintain steady state FIX levels above 12% in individuals with severe hemophilia B. The trial will enroll up to six subjects who will receive a single intravenous dose, followed by daily subcutaneous (SQ) doses of DalcA for 28 days. Pharmacokinetics, pharmacodynamics, safety and tolerability of daily SQ dosing and anti-drug antibody formation will also be monitored. The trial is expected to be completed in the second half of 2019.
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