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Catalyst Updates on Phase 2/3 Trial of Subcutaneous Therapy

August 17, 2018
Catalyst Updates on Phase 2/3 Trial of Subcutaneous Therapy

Catalyst Biosciences recently announced updated positive interim data from a phase 2/3, multinational clinical study of marzeptacog alfa (MarzAA), a subcutaneously administered factor VIIa therapy. MarzAA is being developed by Catalyst for the prophylactic treatment of individuals with hemophilia A or B with inhibitors.

Trial investigators are evaluating MarzAA’s ability to eliminate, or minimize, spontaneous bleeding episodes in patients. Safety and tolerability of the therapy is also being monitored. As many as 12 individuals with hemophilia and an inhibitor will be ultimately enrolled amongst approximately 10 clinical trial sites across the world – thus far five patients have been enrolled. The new update data was presented at the 2018 Hemophilia Drug Development Summit, August 15-16, 2018 in Boston.

According to a Catalyst press release, the first participant to complete the trial earlier this summer had a historic annualized bleeding rate (ABR) of 26.7 and finished the trial with no bleeds after 50 days of treatment with MarzAA. Now two additional patients have completed the trial. One of these participants has a historic ABR of 16.6 and experienced no bleeds for 50 days of treatment with the therapy, while the other patient, with a historic ABR of 15.9, had no bleeds during 44 days of treatment with MarzAA. The company also reports no anti-drug antibodies thus far in the trial.

“The ongoing study of subcutaneous MarzAA for the treatment of hemophilia A or B with inhibitors continues to demonstrate positive interim results, as reflected in the clinical update provided at this year’s Hemophilia Drug Development Summit,” said Nassim Usman, PhD, chief executive officer of Catalyst. “The data from these three individuals support the efficacy of MarzAA to reduce annualized bleed rates after daily subcutaneous injections. Importantly, to date we have not observed any injection site reactions nor any anti-drug antibodies after more than 200 subcutaneous doses of MarzAA.”

Source: Catalyst press release dated August 15, 2018