07:39 AM EDT, 07/24/2024 (MT Newswires) -- Pfizer ( PFE ) said Wednesday its phase 3 study evaluating its investigational gene therapy giroctocogene fitelparvovec in adults with moderately severe to severe hemophilia met its primary and secondary goals of superiority compared with prophylaxis.

After a single dose, participants posted a statistically significant reduction in mean annualized bleeding rates compared to pre-infusion levels, indicating that the study met its primary goal of non-inferiority and superiority over routine Factor VIII replacement, the company said.

Key secondary endpoints of superiority compared with prophylaxis were also met, with 84% of participants maintaining FVIII activity above 5% at 15 months post-infusion, Pfizer ( PFE ) said, adding one patient among all dosed participants of the study returned to prophylaxis post-infusion.

Giroctocogene fitelparvovec was generally well tolerated, with adverse events generally resolved after clinical management, the company added.

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