Filana Therapeutics said it is preparing to restart clinical development of simufilam for epilepsy associated with tuberous sclerosis complex (TSC), after the FDA lifted a clinical hold in September. The company expects to begin screening patients for a Phase 2a study by the first quarter of 2027.
The Austin-based biotechnology company also highlighted new preclinical research on simufilam published in the journal Cells and announced its third-quarter 2026 financial results.
- Clinical study: Filana said it began working to activate study sites after the FDA lifted the hold. Patient screening is expected to start by Q1 2027; the announcement did not provide a specific date or further trial details.
- Research: The company cited a new preclinical paper in Cells that it said offers insights into simufilam’s potential mechanism of action. The announcement did not describe the research findings in detail.
- Disease context: TSC is a rare genetic disorder, and epilepsy is its most common health issue. Filana says about 80% to 90% of people with TSC experience seizures, and more than 60% remain refractory to antiepileptic therapy.
- Financial results: Filana announced results for the quarter ended September 30, 2026, but the release text provided no financial figures.
The FDA’s removal of the hold allows the planned study to move toward patient screening. Simufilam remains an investigational therapy; the announcement provides no clinical evidence that it treats TSC-related epilepsy.