Filana Therapeutics posts corporate presentation on simufilam development for TSC-related epilepsy

Filana Therapeutics, Inc.

Filana Therapeutics, Inc.

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  • Filana Therapeutics outlined plan to develop simufilam for tuberous sclerosis complex-related epilepsy, positioning drug as potential first-in-class oral filamin A modulator.
  • Program remains on FDA clinical hold following December 2025 letter; work underway to address requests for additional preclinical data and protocol modifications ahead of a response.
  • Preclinical package cited anti-seizure activity across two mouse models, including 60% reduction in seizure frequency in Yale RhebCA model.
  • Company highlighted safety database of more than 2,000 prior simufilam-treated subjects, with some exposed up to 24 months.
  • Method-of-treatment patent issued in 2025 was in-licensed from Yale; product supply described as in place for planned proof-of-concept study.


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