Pfizer Resumes Dosing In Phase 3 Hemophilia Gene Therapy Trial Six Months After FDA Lifts Clinical Hold

Pfizer Inc (NASDAQ:PFE) and its partner Sangamo Therapeutics Inc (NASDAQ:SGMO) have reopened enrollment in phase 3 AFFINE study hemophilia A gene therapy trial. …
  • Pfizer Inc (NASDAQ:PFE) and its partner Sangamo Therapeutics Inc (NASDAQ:SGMO) have reopened enrollment in phase 3 AFFINE study hemophilia A gene therapy trial. 
  • Trial sites will begin to resume enrollment this month, with dosing expected to restart in October.
  • The study will evaluate the efficacy and safety of a single infusion of giroctocogene fitelparvovec in more than 60 adult male participants with moderately severe to severe hemophilia A. 
  • The primary endpoint is the impact on annualized bleeding rate (ABR) through 15 months following the treatment.
  • Also Read: FDA Gives Green Signal To Pfizer’s Duchenne Gene Therapy Trial.
  • The FDA put the study of giroctocogene fitelparvovec on hold in November 2021. Pfizer hit pause after seeing some patients experience blood clotting protein factor VIII activity greater than 150%. 
  • In March this year, the FDA lifted the clinical hold, but Pfizer kept the voluntary pause in place while working to meet “all necessary conditions,” including approval of updated trial protocols by regulatory authorities. 
  • In May, Sangamo said the trial would start in Q3 of 2022, with data expected in 2H of 2023. The target for the data drop is further delayed to the first half of 2024. 
  • Price Action: PFE shares are down 1.63% at $43.85, and SGMO shares are down 2.97% at $4.89 on the last check Friday.
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