Benzinga | Feb 8, 2021 12:47PM EST

Freeline Therapeutics To Start FLT180a Dose Confirmation Study In Hemophilia B By 2021 End

* Freeline Therapeutics Holdings Plc (NASDAQ: FRLN) has modified its FLT180a clinical development plan for Hemophilia B to address feedback received from the FDA regarding the characterization and comparability of FLT180a used in its Phase 1/2 B-AMAZE trial.

* Freeline now plans to conduct dose confirmation in a Phase 1/2 trial instead of Phase 2b part of the previously planned Phase 2b/3 trial. The dose confirmation trial could commence by the end of 2021.

* Data readout for the Phase 1/2 dose confirmation trial is expected by the end of 2022. Phase 3 study is expected to start by the middle of 2023, and filing of a marketing application is anticipated by the end of 2024.

* The Phase 1/2 dose confirmation trial will be a six-month single-dose safety and efficacy trial designed to confirm the dose and immune management regimen for the planned Phase 3 pivotal trial. Informed by the dose-ranging B-AMAZE trial results, which demonstrated a dose-response across four cohorts, the Company believes that a dose of FLT180a between 7.5e11 and 9.75e11 vg/kg is likely to bring patients into the normal range of Factor IX activity level of 50-150%.

* Price Action: FRLN stock is trading lower by 6.06% at $16.29 on the last check Monday.