Cognition Therapeutics (NASDAQ: CGTX) has announced that it will move its oral sigma‑2 receptor modulator, zervimesine (CT1812), into a registrational program for dementia with Lewy bodies (DLB) psychosis. The new study will enroll patients with neuropsychiatric symptoms—including hallucinations, delusions, anxiety, aggression and agitation—using a randomized, placebo‑controlled design and a 100 mg daily dose.
Phase 2 SHIMMER data, which the company cited in the announcement, showed an 86 % slowing of decline on the 12‑item neuropsychiatric inventory (NPI‑12) and no worsening of motor function. The data suggest that zervimesine can address the core behavioral symptoms of DLB psychosis without the motor side effects that limit the use of conventional antipsychotics.
Cognition plans to meet with the FDA’s Division of Psychiatry by mid‑2026 to discuss the DLB psychosis program. A Type C meeting was held on January 21 2026, and the company is pursuing a fast‑track or accelerated approval pathway if the agency’s feedback is favorable.
The move expands Cognition’s pipeline beyond Alzheimer’s disease and geographic atrophy, positioning zervimesine as a potential first‑in‑class therapy for an underserved patient population. Oral dosing and the absence of ARIA risk are highlighted as therapeutic advantages over existing treatments, which are limited and often contraindicated in DLB patients.
Financially, Cognition reported that it had approximately $39.8 million in cash and $36.3 million in remaining National Institute on Aging grant funds as of Q3 2025, giving the company a runway into Q2 2027. A $30 million registered direct offering closed in September 2025, but the company still seeks a partnership or additional funding to support the costly Phase 3 development and address ongoing cash runway concerns.
Management emphasized the unmet need and the drug’s potential impact. Chief Medical Officer Anthony O. Caggiano said, “Based on the Agency’s meeting minutes and the strength of our Phase 2 ‘SHIMMER’ data in the psychiatric and behavioral domain, we believe the best strategy is to pursue a registrational path for the treatment of DLB psychosis.” President and CEO Lisa Ricciardi added, “We showed in Phase 2 that zervimesine’s impact on neuropsychiatric symptoms did not impair participants’ motor skills. In fact, zervimesine had a directionally favorable impact on cognitive fluctuations, memory, movement, and activities of daily living.”
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