Cassava Sciences Discontinues Developing Simufilam For Alzheimer's After Another Phase 3 Trial Flop

Cassava Sciences Inc. (NASDAQ:SAVA) on Tuesday shared topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimer’s disease.

REFOCUS-ALZ randomized approximately 1,125 people utilizing the same eligibility criteria as RETHINK-ALZ.

Topline data indicate that REFOCUS-ALZ did not meet each of the prespecified co-primary, secondary and exploratory biomarker endpoints.

Also Read: Cassava Sciences Alzheimer’s Drug Fails To Hit Primary Goal In Pivotal Study, Pharma Halts Late-Stage Studies

The co-primary endpoints were the change in cognition and function from baseline to the end of the double-blind treatment period at week 76, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to placebo.

On ADAS-COG12 (cognitive scale, where lower numbers mean less cognitive impairment), scores rose by 4.97 and 5.26 points in the two simufilam cohorts and by 4.70 points in the placebo group.

Similarly, on ADCS-ADL (daily living where a higher number represents less functional impairment), scores fell by 6.27 and 6.43 points on simufilam arms and by 5.32 points on placebo. 

REFOCUS-ALZ was discontinued in November following the report that a prior 52-week Phase 3 study, RETHINK-ALZ, did not meet its co-primary endpoints.

A large portion of subjects enrolled in REFOCUS-ALZ completed their final study visit prior to the termination of the trial. Simufilam continued to demonstrate an overall favorable safety profile.

“We are disappointed that the results of REFOCUS-ALZ and RETHINK-ALZ showed no treatment benefit for patients with mild-to-moderate Alzheimer’s disease. These results were unambiguous,” said Cassava Chief Executive Rick Barry.

“Cassava will discontinue all efforts to develop simufilam for Alzheimer’s disease and we expect to phase out the program by the end of Q2 2025,” Barry continued.

In February, Cassava Sciences entered into an agreement with Yale University for a license to intellectual property rights, including an exclusive license to an issued US method of treatment patent for simufilam as a potential treatment for seizures related to rare neurodevelopmental disorders, including tuberous sclerosis complex.

Price Action: SAVA stock is down 22.1% at $2.18 at the last check Tuesday.

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