Filana Therapeutics Presents Phase 2a Simufilam Study Plans for TSC-Related Epilepsy

PUBT · 18h ago
Filana Therapeutics Presents Phase 2a Simufilam Study Plans for TSC-Related Epilepsy
  • Filana Therapeutics expects screening for its Phase 2a simufilam study in TSC-related epilepsy to begin by Q1 2027; FDA clinical hold lifted.
  • The randomized, double-blind study will enroll approximately 40 patients ages 12-55 across 13 U.S. sites.
  • Two simufilam doses will be added to standard care, with safety, tolerability and pharmacokinetics as primary endpoints.
  • Simufilam reduced seizure frequency by 60% in the Yale mouse model; a second model showed dose-dependent attenuation of increased seizure activity.
  • Prior clinical studies treated more than 2,000 individuals, with no drug-related serious adverse events reported.


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