Cassava Sciences’ Stock Craters 84% as Alzheimer’s Drug Trial Hits a Wall

Cassava Sciences (NASDAQ: SAVA) shares fell sharply on Monday, dropping 84% following the release of Phase 3 trial results for its Alzheimer’s drug, Simufilam. The trial, part of the ReThink-ALZ study, failed to meet its co-primary endpoints, showing no statistically significant improvement in cognitive or functional decline compared to a placebo after 52 weeks of treatment.

The trial included 804 participants with mild to moderate Alzheimer’s disease. Simufilam was evaluated using two key scales, ADAS-COG12 and ADCS-ADL, which measure cognitive impairment and daily living activities, respectively. Neither measure showed significant differences from the placebo group.

Key Details:

• Results: Simufilam failed to demonstrate efficacy in reducing cognitive or functional decline over the 52-week study period.
• Safety Profile: The drug maintained an overall favorable safety profile, with no unexpected adverse events reported.
• Stock Impact: The stock’s plunge marked its biggest single-day percentage decline on record, hitting its lowest level since 2020.

Cassava’s CEO, Rick Barry, called the results “disappointing” and noted that further analysis is underway to better understand the placebo group’s unexpected performance. “We took careful measures to enroll patients with mild-to-moderate Alzheimer’s disease,” Barry said. “Despite that, the loss of cognition in the placebo group was less pronounced than in prior studies.”

Company’s Financial Position:

Despite the trial setback, Cassava remains financially stable, with CFO Eric Schoen reporting approximately $149 million in cash and cash equivalents as of Q3 2024. Schoen stated that the company will continue to review trial data and determine next steps.

ReThink-ALZ Trial Background:

ReThink-ALZ is a Phase 3 study conducted across over 75 clinical sites in the U.S., Canada, and Australia. The trial was designed to evaluate Simufilam’s safety and efficacy under a Special Protocol Assessment (SPA) with the FDA.

The company plans to present detailed study results at an upcoming medical meeting. Cassava’s pipeline and future steps remain under evaluation as it aims to navigate this significant setback.