Cassava Sciences Completes Patient Enrollment for Pivotal Phase 3 Clinical Trial of Oral Simufilam in Alzheimer’s Disease
Monday, October 02, 2023
Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company, today announced the completion of patient enrollment in a pivotal Phase 3 clinical trial. Eight hundred four (804) Alzheimer’s patients are enrolled in this 12-month trial. A second Phase 3 clinical trial with a target enrollment of approximately 1,100 patients is expected to complete patient enrollment in Q4 2023. Both on-going Phase 3 clinical trials are evaluating the safety and efficacy of oral simufilam in patients with Alzheimer's disease dementia.
Simufilam is Cassava Sciences’ proprietary oral drug candidate. This investigational drug binds to altered filamin A protein in the brain and restores its normal shape and function. By targeting altered filamin A, simufilam may help patients with Alzheimer’s achieve better health outcomes.
Today’s news comes on the heels of a recently announced positive interim safety review of simufilam in Cassava Sciences’ on-going Phase 3 clinical trials in Alzheimer’s disease. A recent meeting of a Data and Safety Monitoring Board (DSMB) recommended that both Phase 3 studies of simufilam continue as planned, without modification.
“We are pleased to announce the completion of patient enrollment in our first pivotal Phase 3 trial of simufilam in Alzheimer’s,” said James Kupiec, MD, Chief Medical Officer. “We are grateful to the patients, investigators and our CRO who have helped achieve this milestone.”
“Cassava Sciences is honored to be developing a new drug treatment for people living with Alzheimer’s disease,” said Remi Barbier President & CEO. “Alzheimer’s is a medical condition with high unmet needs. It merits the development of drug innovations that aim to go beyond removing amyloid from the brain. We think simufilam is advancing towards that goal.”
About Cassava Sciences, Inc.
Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. Our product candidates have not been approved by any regulatory authority, and their safety and efficacy have not been established in humans.
For more information, please visit: https://www.CassavaSciences.com
For More Information Contact:
Eric Schoen, Chief Financial Officer
(512) 501-2450
ESchoen@CassavaSciences.com
