Filana Therapeutics plans Phase 2a simufilam trial in TSC-related epilepsy after FDA lifts clinical hold
FLNA•FDA lifts clinical hold on simufilam IND
Filana Therapeutics plans Phase 2a simufilam trial in TSC-related epilepsy after the FDA lifted a clinical hold on its IND.
Patient screening for a Phase 2a proof-of-concept trial is expected to start in Q1 2027; no study results have been presented yet.
The 16-week randomized, double-blind study targets 40 patients ages 12 to 55 across 13 U.S. sites, with an optional 48-week extension.
Readout is expected to guide next-stage development decisions, including whether to expand into younger patient groups.
