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www.fdanews.com/articles/210979-cassava-claims-phase-2-win-for-its-alzheimers-candidate

Cassava Claims Phase 2 Win for Its Alzheimer’s Candidate

January 30, 2023

Cassava Sciences is claiming a phase 2 win with its investigational Alzheimer’s treatment simufilam in patients with mild-moderate disease — but the open-label study lacks a placebo comparator, and the topline numbers didn’t come with context indicating their statistical validity.

Numbers the company did share show the drug candidate is about as useful as placebo for people with Alzheimer’s disease.

Cassava had previously made claims that simufilam improves cognition — something no investigational Alzheimer’s drug has ever been shown to do. Other drugs under development now only purport to slow decline.

In its latest study results, Cassava reported that 47 percent of patients improved on the main cognitive endpoint, the Alzheimer’s disease assessment scale — cognitive.

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