Cassava Sciences Expands Open-Label Extension Trials

Cassava Sciences, Inc. has announced an extension of up to 36 months for its ongoing open-label extension trials of simufilam in Alzheimer’s disease. This decision allows participants who have previously taken part in a randomized trial of simufilam to continue their treatment if they wish, pending the results of ongoing pivotal Phase 3 trials. This extension aims to bridge any potential gaps between the end of a clinical trial and the reporting of results to regulatory authorities.

The company is also planning to incorporate cognition and plasma biomarker monitoring in these open-label extension trials to collect additional long-term data on the effects of simufilam treatment. Rick Barry, the Executive Chairman of Cassava, emphasized that expanding these studies is a significant commitment but is ultimately beneficial for the patients they serve.

Currently, about 89% of patients in Cassava's Phase 3 program have opted to continue with open-label treatment after the completion of blinded trials. Prior to this extension, around 100 patients had completed the open-label Phase 3 extension trial and had no further treatment options. Now, these patients can re-enroll in the open-label extension trial if they choose.

James Kupiec, MD, Chief Medical Officer of Cassava, highlighted that this decision aligns with the company's commitment to meet patient needs, responding directly to requests from clinical research sites.

Cassava is conducting two major Phase 3 studies of simufilam targeting patients with mild-to-moderate Alzheimer’s disease dementia. The first study, RETHINK-ALZ, is a 52-week trial involving 804 patients randomized equally between simufilam 100 mg and a placebo. The second study, REFOCUS-ALZ, spans 76 weeks with 1,125 patients randomized into three groups receiving simufilam 100 mg, simufilam 50 mg, or a placebo. These trials are being conducted across 172 clinical sites in the U.S., Canada, Puerto Rico, Australia, and South Korea.

The company anticipates releasing top-line results for RETHINK-ALZ by the end of 2024, with results for REFOCUS-ALZ expected by mid-2025.

The open-label extension studies are designed to offer Alzheimer’s patients who have successfully completed a Phase 2 or Phase 3 simufilam study continued, no-cost access to the medication. Each clinical investigational site will decide whether to participate in these open-label extension studies.

Cassava has made these changes to address the needs and requests of the clinical research community and to ensure that patients have ongoing access to potentially beneficial treatment while awaiting the results of larger, controlled trials. The company's efforts underscore its commitment to advancing Alzheimer’s disease treatment and improving patient outcomes through prolonged and meticulous clinical research.