- Freeline Therapeutics Holdings plc (NASDAQ: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.
- Price Action: FRLN shares are down 10.10% at $0.99 during the market session on the last check Monday.
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