Cassava Sciences' Controversial Alzheimer's Drug Fails To Hit Primary Goal In Pivotal Study, Halts Late-Stage Studies

On Monday, Cassava Sciences Inc. SAVA stock plunged after the company released topline data from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate Alzheimer’s disease.

The trial did not meet the pre-specified co-primary, secondary, and exploratory biomarker endpoints.

In July, CEO Rick Barry wrote a letter to shareholders and employees, saying that the company is in the final stages of testing simufilam and has significant financial and emotional stakes.

The co-primary endpoints were the change in cognition and function from baseline to the end of the double-blind treatment period at week 52, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to placebo.

Simufilam continued to demonstrate an overall favorable safety profile.

“The results are disappointing…We took careful measures to enroll patients with mild-to-moderate AD. Despite that, the loss of cognition in the placebo group was less pronounced than was previously reported in other placebo-controlled studies in AD…” said Rick Barry, President and Chief Executive Officer.

The company said the failed trial results have impacted its second Phase 3 trial, ReFocus-ALZ, and decided to discontinue ReFocus-ALZ. The company will also be discontinuing the Open Label Extension study.

The complete 52-week dataset will be available from the study along with a large portion of 76-week data.

Cassava will continue to review the data and evaluate the next steps. We plan to share the detailed results at a future medical meeting.

Cassava has been in the headlines for fabricating data from simufilam drug trials.

In September, Cassava Sciences agreed to pay over $40 million to resolve SEC charges over misleading statements related to a Phase 2 trial of the company’s controversial Alzheimer’s drug, simufilam.

The SEC also charged Hoau-Yan Wang, a consultant and co-developer of the drug, with manipulating trial results.

The SEC’s investigation found that in September 2020, Cassava disclosed manipulated data from the trial, which falsely suggested dramatic improvements in Alzheimer’s biomarkers like total tau and phosphorylated tau.

Price Action: SAVA stock is down 84.2% at $4.19 during the premarket session at last check Monday.

Photo via Shutterstock

Read Next:

• FDA Approves BridgeBio Pharma’s Drug For Rare Heart Disease, Poised To Challenge Pfizer In Lucrative Yet Competitive Market