FRLN - Freeline gains as NEJM publishes long-term data for hemophilia therapy

• Clinical-stage biotech Freeline Therapeutics ( NASDAQ: FRLN ) traded higher in the pre-market Thursday after the company announced that the New England Journal of Medicine (NEJM) published long-term follow-up data from its Phase 1/2 B-AMAZE trial for hemophilia B therapy FLT180a.
• Hemophilia B is a hereditary bleeding disorder characterized by a deficiency in coagulation factor IX (FIX). With a data cut off of Sep. 20, 2021, the publication included follow-up data for up to 3.5 years. A gene therapy candidate, FLT180a is currently undergoing a Phase 1/2 dose-confirmation trial.
• Highlights of the NEJM article prepared by Pratima Chowdary et al. include dose-dependent increases in FIX levels in all patients after FLT180a therapy.
• In addition, nine out of 10 patients were found to have a sustained FIX activity at a median follow-up of 27.2 (19.1-42.4) months.
• Following FLT180a therapy, the mean annualized bleeding rate across all patients dropped to 0.71 (0-1.7) events/year from 2.93 (0-7.33) events/year at baseline.

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