Catalyst Biosciences provided an update on enrollment in its 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. Two subjects have completed dosing and washout, Factor IX levels in these two subjects exceeded the trial efficacy endpoint of >12% activity and no anti-drug antibodies were detected. Enrollment is ongoing and the Company anticipates reporting final data in the first half of 2020.
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“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,” said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. “We are very pleased with the FIX activity and lack of ADAs obtained and look forward to providing final data in the first half of 2020.”
The open-label Phase 2b study is evaluating the ability of DalcA to maintain steady state FIX levels above 12% in individuals with severe hemophilia B. The trial is expected to enroll up to six completing 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 are being monitored. The trial is actively enrolling and study participants have been identified.