Cognition Therapeutics Secures Second Philanthropic Donation to Extend Zervimesine Expanded Access Program in DLB

With no approved treatments for dementia with Lewy bodies and a registrational meeting with FDA's Division of Psychiatry expected in Q2 2026, Cognition Therapeutics' expanded access program for zervimesine (CT1812) is carrying more regulatory weight than a typical compassionate-use arrangement. A second philanthropic donation, from Jeffrey Pechter, founding partner of Mindful Capital, has extended the open-label COG1202 EAP to two years of treatment for its 32 enrolled participants.

The program, launched in 2025 following positive Phase 2 SHIMMER study findings, administers 100 mg once-daily oral zervimesine to individuals with mild-to-moderate DLB who either completed SHIMMER or met separate enrollment criteria. The first donation came from the family of a SHIMMER participant; both contributions are sustaining a program that would otherwise lack a commercial or grant funding base. For regulatory affairs leads, the structure is notable: philanthropically funded EAPs in rare neurological indications can generate longitudinal safety and tolerability data that directly informs FDA pre-NDA dialogue.

James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and lead EAP investigator, has indicated that findings from the program will shape plans for the registrational trial design. That framing positions COG1202 not merely as a patient-access mechanism but as a data-generating bridge between Phase 2 and a pivotal program, a use of EAP infrastructure that QA and regulatory teams in rare-disease development will recognise as increasingly common under 21 CFR Part 312 Subpart I expanded access provisions.

The scheduled FDA meeting will determine the structure of next-stage trials evaluating zervimesine specifically in DLB psychosis, a sub-indication with no approved pharmacotherapy. Meeting minutes, also anticipated in Q2 2026, will set the parameters that define Cognition's registrational path and, by extension, the scope of any future manufacturing scale-up and process validation requirements for the small-molecule candidate.

The measurable checkpoint ahead is the FDA Division of Psychiatry meeting and its subsequent minutes, both expected before the end of Q2 2026, which will determine whether the registrational program proceeds as a single pivotal study or a multi-trial package.

Source: Cognition Therapeutics, Inc. via GlobeNewswire, 14 May 2026.