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Cassava Sciences announces agreement with FDA

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Published:25th Aug 2021
Cassava Sciences announced that it has reached agreement with the FDA under a Special Protocol Assessment (SPA) for both of its pivotal Phase III studies of oral simufilam for the treatment of patients with Alzheimer’s disease.

These SPA agreements document that FDA has reviewed and agreed upon the key design features of Cassava Sciences’ Phase III study protocols of simufilam for the treatment of patients with Alzheimer’s disease.

Cassava Sciences also reaffirmed prior guidance to advance simufilam into a Phase III pivotal program in Alzheimer’s disease in Fall 2021. The first clinical study protocol under the SPA is titled “A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 52-Week Study Evaluating the Safety and Efficacy of One Dose of Simufilam in Subjects with Mild-to-Moderate Alzheimer's Disease”. The second clinical study protocol under the SPA is titled “A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 76-Week Study Evaluating the Safety and Efficacy of Two Doses of Simufilam in Subjects with Mild-to-Moderate Alzheimer’s Disease”.

Condition: Alzheimers
Type: drug

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