Cognition Therapeutics (NASDAQ: CGTX) has extended the duration of its expanded access program (EAP) for its oral sigma‑2 receptor modulator, zervimesine (CT1812), in patients with dementia with Lewy bodies (DLB). The extension, announced on February 5 2026, adds several months to the original 12‑month treatment window, allowing the company to collect additional long‑term safety data that will support the design and regulatory strategy for upcoming Phase 3 trials.
The EAP now includes 32 participants across eight sites, each receiving 100 mg of zervimesine daily. The program’s patient‑centric design—enabling local physicians to conduct routine monitoring and laboratory testing—has received positive feedback from participants and caregivers, reducing travel burdens and improving adherence. The extension is part of Cognition’s broader DLB development program, which also features the Phase 2 SHIMMER study and planned pivotal trials.
Zervimesine is a sigma‑2 receptor modulator that blocks the accumulation of toxic proteins such as amyloid‑beta and alpha‑synuclein, the pathological hallmarks of Alzheimer’s disease and DLB. The SHIMMER study demonstrated clinically meaningful improvements in cognition, behavior, function, and motor symptoms, positioning the drug as a promising disease‑modifying candidate in a market with no approved therapies.
By extending the EAP, Cognition aims to strengthen its safety profile ahead of regulatory submissions and potential partnership discussions. The additional data will help the company define clinically meaningful endpoints for future trials and address a key risk in its single‑asset, multi‑indication strategy. Chief Medical Officer Anthony O. Caggiano noted that the program’s design “has been running since June 2025 and is expected to provide us with additional long‑term safety data. We have received favorable feedback from participants and their care partners about their experience in this program.”
The extension also aligns with recent regulatory engagement. Cognition held a Type C meeting with the FDA on January 21 2026 to discuss SHIMMER findings and future DLB endpoints, and the company’s ongoing dialogue signals a proactive approach to meeting regulatory expectations for a disease‑modifying therapy in a high‑need indication.
The EAP was initially funded by an anonymous philanthropic donation, and Cognition has recently completed a $30 million registered direct offering in September 2025 to support late‑stage development. The company’s cash runway and funding strategy position it to sustain the extended program while advancing toward pivotal trials.
Overall, the EAP extension represents a strategic step to gather robust safety data, enhance patient experience, and strengthen the regulatory pathway for zervimesine in DLB, reinforcing Cognition’s position in a competitive neurodegenerative disease landscape.
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