- Ongoing open-label extension trials of simufilam in Alzheimer’s disease to be extended by up to an additional 36 months.
- The extension provides participants the opportunity to continue on treatment, if they desire, pending results of the ongoing pivotal Phase 3 trials.
- Company plans to add cognition and plasma biomarker monitoring to the open-label extension trials to gather additional long-term data on simufilam treatment.
AUSTIN, Texas, July 30, 2024 (GLOBE NEWSWIRE) — Cassava Sciences, Inc. (Nasdaq: SAVA) today announced that the Company will extend by up to an additional 36 months each of the open-label extension trials in its ongoing Phase 2 and Phase 3 clinical programs. These amendments to the protocols will allow patients who have previously participated in a randomized trial of simufilam in Alzheimer’s disease, if they desire, to continue open-label treatment with simufilam. This expansion of the open-label extension trials offers a bridge for any gap between patients ending treatment in a clinical trial and the Company reporting to regulatory authorities the results of the ongoing, randomized, placebo-controlled Phase 3 trials. The open-label extension can continue for up to 36 months or until a new drug application for simufilam has been reviewed by FDA.
Cassava also plans to add cognition and plasma biomarker monitoring to its open-label extension trial for patients who have completed the Phase 3 trials in order to gather additional long-term data on the potential impact of simufilam treatment.
“For a company of our size, it is not a trivial commitment to expand our open-label extension studies in this manner. But we believe that this is the best answer for our patients and, ultimately, that is who we serve,” said Cassava Executive Chairman Rick Barry.
Approximately 89% of patients in Cassava’s ongoing Phase 3 program have elected to continue with open-label treatment with simufilam after completion of the blinded trials. Prior to this announced change, approximately 100 patients completed the open-label Phase 3 extension trial and had no option but to discontinue treatment. These patients will now be given the opportunity to re-enroll in an open-label extension trial, if they choose to do so.
James Kupiec, MD, Cassava’s Chief Medical Officer stated, “This decision by the Company is consistent with our commitment to patients. We have expanded the open-label trials in direct response to requests from our clinical research sites.”
Ongoing Phase 3 Studies of Simufilam in Alzheimer’s Disease
Cassava is currently running two double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. RETHINK-ALZ is a 52-week trial in which 804 patients were randomized 1:1 between simufilam 100 mg and placebo. REFOCUS-ALZ is a 76-week trial in which 1,125 patients were randomized 1:1:1 between simufilam 100 mg, simufilam 50 mg, and placebo. The trials are being conducted at 172 clinical sites in the United States, Canada, Puerto Rico, Australia, and South Korea.
The Company expects to announce top-line results of RETHINK-ALZ by the end of 2024. Top-line results for REFOCUS-ALZ are anticipated approximately mid-2025.
Open-label Extension Study Design
These studies are designed to provide no-cost access to oral simufilam to Alzheimer’s patients who have successfully completed a Phase 2 or Phase 3 study of simufilam and who meet other entry criteria. Each clinical investigational site must choose whether to participate in the open-label extension studies.
For more information about the Phase 3 open-label-extension study, please visit ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT05575076?term=simufilam&draw=2&rank=1
Cautionary Note Regarding Forward-Looking Statements:
This letter contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that may include but are not limited to statements regarding: our ability to extend our existing open-label extension trials, as contemplated or at all; clinical trials of Cassava’s product candidates; and the potential benefits, if any, of Cassava’s product candidates. These statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “may,” “opportunities,” “plan,” “possible,” “potential,” “will,” and other words and terms of similar meaning. Such statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those described in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and future reports filed with the SEC. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this letter are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking statements.
Cassava’s clinical results from earlier-stage clinical trials may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data the Company presents or publishes or has presented or published previously.
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