The ongoing EAP has been extended to provide two years of treatment for participants, thanks to a generous new donation from Mr. Jeffrey Pechter, founding partner of Mindful Capital in Delray Beach, FL.
The open-label EAP (COG1202) was launched in 2025 with funding by a generous donation from the family of a DLB patient who was treated in the Phase 2 SHIMMER study. The EAP has since enrolled 32 individuals who are receiving 100 mg of once-daily oral zervimesine, a small molecule investigational therapy designed to protect synaptic function in patients with neurodegenerative diseases.
"We continue to be inspired by the high degree of interest in zervimesine from DLB patients and the commitment from people participating in the EAP," said Lisa Ricciardi, president and CEO of Cognition Therapeutics. "The lack of approved treatments for DLB and the limited availability of clinical research leaves people living with DLB with few options. Due to the overwhelming generosity of our two philanthropic donors, we are able to offer expanded access to zervimesine to the 32 people in our EAP."
James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine, and lead investigator for the EAP, added. "The EAP is a unique opportunity for former participants from the Phase 2 SHIMMER study as well as others who met the EAP's eligibility criteria to have access to an experimental medication like zervimesine. I'm looking forward to continuing to work with the Cognition team as we learn more about zervimesine's long-term impact and make plans for a registrational program."
Following positive findings from the completed Phase 2 SHIMMER study, Cognition is scheduled to meet with the FDA Division of Psychiatry to discuss next steps for a registrational program evaluating zervimesine in DLB psychosis. The Company's plans for the next trial(s) will be further informed by this meeting with the FDA and subsequent meeting minutes, both of which are expected in the second quarter of 2026.
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