Freeline Posts Cases Of Lower FIX Expression, Higher Liver Enzymes From Hemophilia Candidate

Freeline Therapeutics Holdings plc FRLN announced the presentation of safety and initial efficacy data from the first cohort of the Phase 1/2 B-LIEVE trial for FLT180a for hemophilia B.
As of the data cut-off of May 23, 2022, a one-time FLT180a dose of 7.7e11 vg/kg generated a rapid increase of coagulation factor IX (FIX), reaching levels in the normal range (93, 92, and 80 IU/dL) for the three patients in cohort 1 through days 77, 56 and 36, respectively.
FIX is an essential protein in the process of hemostasis and normal blood clotting.
Patients stopped FIX prophylaxis and did not require FIX replacement or experience bleeding following treatment with FLT180a.
The dosing of cohort two was completed in June, with early results showing similar initial responses to FLT180a.
As the data continue to evolve since the data cut-off for cohort one, two patients have experienced a decrease in FIX expression and a mild and transient increase in liver enzymes.
All patients continue to have expression levels above baseline, and no patient has experienced a bleed or required FIX supplementation.
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