Philanthropic Donor Funds Cognition Therapeutics' Expanded Access Program for Zervimesine (CT1812) in Dementia with Lewy Bodies

Associated Press

03-06-2025

Dr. James Galvin of the University of Miami to Serve as Lead Investigator
First Site Initiated: Banner Sun Health Research Institute
PURCHASE, N.Y., June 03, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the 'Company' or 'Cognition') (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, announced today it has received an anonymous philanthropic donation to substantially fund an expanded access program (EAP) for people with dementia with Lewy bodies (DLB). The generous donation comes from the family of a DLB patient who was treated with zervimesine in the Phase 2 SHIMMER study. Through this open-label EAP, participants will be provided with 100 mg of oral zervimesine to take daily for approximately one year. Banner Sun Health Research Institute in Arizona is the first of eight sites to be activated, with David Shprecher, DO Msci serving as primary investigator at the site.
'At Cognition, our ultimate goal is to create a therapy that changes lives. We are moving as rapidly as possible to onboard participating sites so that we can begin providing zervimesine to eligible patients this month,' stated Lisa Ricciardi, president and CEO of Cognition Therapeutics. 'Throughout the SHIMMER study, we have enjoyed a collaborative relationship with Drs. Galvin and Shprecher and their staffs. Their commitment and that of the Cognition team has been instrumental in launching the EAP so rapidly. Cognition would like to extend our sincere thanks to the benefactor and all stakeholders who made this program a reality.'
Dr. James E. Galvin, MD, MPH, will act as lead investigator for the multi-center, open-label EAP. Dr. Galvin is the director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and was the study director and principal investigator on the SHIMMER study grant from the National Institute of Aging.
Dr. Galvin added, 'As a physician, it's always rewarding when you are able to offer a medication to a patient that may make a meaningful impact on their health. To have touched the anonymous donor's life so meaningfully that they felt compelled to support an expanded access program for so many people is humbling and rewarding. This program is a unique opportunity, and one that my colleagues and I are excited to be involved in.'
Initially, the EAP will be able to accommodate approximately 30 individuals, who will be treated with 100 mg of once-daily oral zervimesine for approximately one year. Additional patients may be treated as funding and drug supply allows. The EAP will be open to eligible SHIMMER participants who completed the Phase 2 study as well as additional patients with a diagnosis of mild-to-moderate DLB who meet the criteria for this program. Eight U.S. sites, all of which were active in the SHIMMER study, were selected to participate in the EAP.
Banner Sun Health Research Institute is the first participating site to be activated. Dr. Shprecher, Banner Health's movement disorder director and a clinical associate professor at the University of Arizona College of Medicine – Phoenix, will serve as the site's EAP investigator. Dr. Shprecher also served as an investigator for the Phase 2 SHIMMER study.
About the EAP
The EAP will operate under a new protocol and will be referred to as COG1202. As an investigational medicine, zervimesine has not been approved by regulatory authorities. Therefore, the safety and efficacy of zervimesine have not been fully characterized and there may be risks associated with its use. If you are a patient or caregiver wishing to know more about this EAP for DLB, we encourage you to discuss this Program with your treating physician. If you are a treating physician and are seeking information about the zervimesine EAP or would like to request access for a patient, please contact [email protected]. More information is available on clinicaltrials.gov under study identifier NCT06961760.
About Cognition Therapeutics, Inc.
Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system. We are currently investigating our lead candidate, zervimesine (CT1812), in clinical programs in dementia with Lewy bodies (DLB) and Alzheimer's disease, including the ongoing START study ( NCT05531656 ) in early Alzheimer's disease. We believe zervimesine can regulate pathways that are impaired in these diseases though its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com.
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