Interim Safety Review of Simufilam Phase 3 Trials Completed

Cassava Sciences, a biotechnology firm centered on Alzheimer's disease, has reported a successful interim safety review for its drug candidate, simufilam, in ongoing Phase 3 trials. The trials are designed to evaluate the efficacy of simufilam in treating Alzheimer's disease dementia. The Data and Safety Monitoring Board (DSMB), a panel of independent experts, has recommended that the trials proceed without any changes.

The company's President & CEO, Remi Barbier, expressed optimism about the interim safety review, stating that the final clinical safety data is anticipated at the end of the Phase 3 program. He also mentioned the expectation of announcing the primary efficacy data from the 12-month Phase 3 study later in the year.

The DSMB's role is solely to oversee patient safety, not to evaluate the drug's effectiveness. The Phase 3 trials for simufilam are fully enrolled with over 1,900 eligible patients with mild-to-moderate Alzheimer's disease. The first trial, with a 52-week treatment period, randomized 804 patients and is expected to release top-line results by the end of 2024. The second trial, with a 76-week treatment period, randomized 1,125 patients, with top-line results expected in mid-2025.

Participants in the trials were recruited from various clinical sites, including the U.S., Puerto Rico, Canada, Australia, and South Korea. Cassava Sciences collaborates with Premier Research International, a global contract research organization, in conducting these trials.

Simufilam is a novel, small molecule drug candidate that targets an altered protein in the brain, potentially improving health outcomes for Alzheimer's patients. Cassava Sciences holds exclusive rights to its investigational product candidates and technologies, free from royalty obligations to third parties.

The company is based in Austin, Texas, and is dedicated to the detection and treatment of neurodegenerative diseases, with a focus on stabilizing a critical brain protein as part of its innovative approach.