Filana leaves Cassava roots behind amid branch into epilepsy

 Cassava Sciences has rebranded as Filana Therapeutics, shedding the baggage associated with the old name as the biotech plants itself in a new therapeutic area.

As Cassava, the biotech mounted a failed attempt to show that its simufilam could improve outcomes in Alzheimer’s disease. By the time the phase 3 data sank the Alzheimer’s program last spring, Cassava was facing a Department of Justice (DOJ) investigation and class-action litigation tied to alleged scientific misconduct and misleading statements. The company recently reached settlements in the DOJ case and class-action lawsuit.

Filana CEO Rick Barry said in Tuesday's announcement that the rebrand represents a “new beginning.” He explained that the company is centering its identity on filamin A, a scaffolding protein involved in neuronal development, which “reflects our dedication to rigorous scientific discovery and to bringing new treatment options to patients and their families.”

Simufilam binds filamin A. During its Alzheimer’s era, the company hypothesized that simufilam targeted the altered form of filamin A in the brains of patients with the neurodegenerative disease to restore its shape and function. Today, Filana aims to treat central nervous system disorders, such as tuberous sclerosis complex (TSC)-related epilepsy, by modulating the protein.

Building on animal tests linking simufilam to reductions in focal-onset seizures, Filana previously planned to start a proof-of-concept study of the small molecule in TSC-related epilepsy in the first half of this year. However, the FDA requested more information on the risks to patients in December and formally put the planned trial on clinical hold later that month. 

Delayed by the hold, the company has abandoned its target of starting the study before mid-2026. Filana said it needs to provide additional preclinical data and modify the protocol design to get the FDA to lift the hold, which the company plans to do this year.

The delay is eating into Filana’s cash runway. Having had $106.1 million as of Sept. 30, Filana estimated it would end 2025 with $92 million to $96 million. The company said in November that it expected its cash to support operations into 2027.

https://www.fiercepharma.com/marketing/filana-leaves-cassava-roots-behind-amid-branch-epilepsy-0