- Freeline Therapeutics Holdings plc FRLN has decided to focus its resources on FLT201 in Gaucher disease and FLT190 in Fabry disease.
- The company will stop investment in further development of FLT180a without a partner.
- Additionally, Freeline announced updated data from the two patients treated in the first cohort from the MARVEL-1 Phase 1/2 trial of FLT190 at a dose of 7.5e11 vg/kg.
- People with classic Fabry disease have little to no functional α-Gal A enzyme.
- Data exhibited elevated α-Gal A levels sustained for up to three years in Patient 1 and one year in Patient 2, with Patient 2 continuing to remain off enzyme replacement therapy (ERT).
- FLT190 has been well-tolerated.
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- No long-term cardiac sequelae have been observed following the early and transient mild myocarditis in both patients. The myocarditis resolved on its own in both patients.
- Freeline initiated dosing in the second cohort (1.5e12 vg/kg) in September 2022.
- The initial safety and efficacy data from the second cohort is expected in 1H of 2023
- The initial safety and efficacy data from FLT201 in Gaucher disease is expected in 1H of 2023, with updated data in 2H of 2023.
- The company is reducing its workforce by approximately 30 employees. This reduction would bring Freeline's headcount to approximately 100 employees by the end of 2022.
- Freeline has also agreed to sell its CMC-focused subsidiary in Germany to Ascend Gene and Cell Therapies Ltd for $25 million.
- Unrestricted cash and cash equivalents of $65.8 million, plus the anticipated proceeds from the sale of Freeline, will enable the company to fund its planned operations into 2024.
- Price Action: FRLN shares traded lower by 5.24% at $0.6494 on the last check Tuesday.
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