Philanthropic Donor Enables Cognition Therapeutics’ Expanded Access Program For Zervimesine (CT1812) In Dementia With Lewy Bodies

Cognition Therapeutics, Inc., a clinical-stage company focused on developing treatments for neurodegenerative diseases, has announced the launch of an expanded access program (EAP) for individuals diagnosed with dementia with Lewy bodies (DLB). This program is made possible by a generous anonymous philanthropic donation from the family of a DLB patient who previously received the company’s investigational drug, zervimesine, during the Phase 2 SHIMMER study.

The EAP will provide eligible participants with 100 mg of oral zervimesine to be taken once daily for about one year. Initially, the program is expected to enroll approximately 30 participants, with the potential to include additional patients depending on future availability of funding and drug supply. The program is open to individuals who completed the SHIMMER trial as well as new patients with a confirmed diagnosis of mild-to-moderate DLB who meet eligibility criteria.

Dr. James E. Galvin, MD, MPH, will serve as the lead investigator for this multi-center, open-label EAP. Dr. Galvin is director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and was previously the principal investigator for the SHIMMER study, which was funded by the National Institute on Aging. The EAP will operate across eight clinical sites in the United States, all of which were involved in the SHIMMER study. 

Lisa Ricciardi, president and CEO of Cognition Therapeutics, stated, “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. 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. Galvin stated, “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.”

Banner Sun Health Research Institute in Arizona is the first site to begin enrolling participants. Dr. David Shprecher, DO, MSci, director of movement disorders at Banner Health and a clinical associate professor at the University of Arizona College of Medicine, Phoenix will serve as the site’s EAP investigator. He also participated as an investigator in the earlier Phase 2 trial. This expanded access initiative reflects Cognition Therapeutics’ commitment to supporting the DLB community by making investigational treatments more widely available while continuing to advance clinical development.