A Phase 2 trial of Catalyst Biosciences' (NASDAQ:CBIO) subcutaneous (SQ) Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA) for prophylaxis met the primary endpoint of significantly reducing the annualized bleed rate (ABR) in patients with hemophilia A or B with inhibitors.
The study also met all secondary endpoints of safety, tolerability and lack of anti-drug antibody or inhibitor formation.
Daily SQ administration for 50 days at an individual’s final dose of MarzAA significantly reduced the mean 6-month pre-study ABR from 19.8 to 1.6 and Proportion of Days with Bleeding (PDB), from 12.3% to 0.8%, during treatment.
The median ABR and PDB were both reduced to zero.
The Company will host a conference call today, at 8:00 a.m. EDT to discuss the MarzAA and DalcA data.
Shares are down 2% premarket.
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