Filana Therapeutics’ Simufilam Reduces Seizures Dose-Dependently in TSC Mouse Over 20-Day EEG
Filana Therapeutics published Epilepsia data demonstrating oral simufilam dose-dependently reduced seizure count and duration in the severe Tsc1-cKO mouse model over 20 days of EEG monitoring. The results strengthen the rationale for simufilam in the U.S. TSC population of ~45,000 and support efforts to resolve the FDA clinical hold.
1. Epilepsia Publication Details
Filana Therapeutics published on April 14, 2026 a paper in Epilepsia titled “The small molecule simufilam dose-dependently attenuates the worsening of seizures in a mouse model of tuberous sclerosis complex.” The study was led by Neuroscience SVP Angélique Bordey at Filana and included collaborators from Yale School of Medicine and the TSC Alliance Preclinical Consortium.
2. Preclinical Efficacy Findings
The dose escalation study used the Tsc1-cKO mouse, a severe model of TSC-related epilepsy, monitoring seizures by EEG over approximately 20 days. Simufilam doses correlated with reduced seizure count and duration compared to vehicle, demonstrating dose-dependent attenuation of progressive seizure activity.
3. Clinical Hold and Next Steps
Filana continues to address the FDA’s clinical hold questions by submitting additional preclinical data and protocol modifications. The company plans to respond to the FDA request following completion of these activities and expects to update its TSC-related epilepsy program in the coming months.