Cognition Therapeutics (NASDAQ:CGTX) shares gained 5% after the company announced that it had received written feedback from the U.S. Food and Drug Administration regarding the development pathway for zervimesine (CT1812) in patients with psychosis associated with dementia with Lewy bodies.
The regulatory update provided clarity on the company’s proposed late-stage development strategy and was viewed positively by investors.
FDA Aligns With Company on Pivotal Study Design
According to Cognition Therapeutics, the FDA agreed that psychosis linked to dementia with Lewy bodies could serve as an approvable indication and aligned with the company on several key components of a pivotal clinical trial intended to support a future New Drug Application (NDA).
The company expects to launch its registrational program in mid-2027.
The feedback represents an important milestone for the development of zervimesine and provides a clearer regulatory pathway toward potential commercialization.
Planned Phase 3 Trial Targets Psychosis Symptoms
The proposed Phase 3 study will focus on patients with dementia with Lewy bodies who experience psychosis-related symptoms, including hallucinations and delusions.
Individuals receiving stable treatment with off-label antipsychotic medications will be eligible to participate in the study.
Following screening, participants will be randomly assigned to receive either a once-daily 100 mg oral dose of zervimesine or a placebo over a nine-month treatment period.
The trial is designed to evaluate whether zervimesine can meaningfully improve psychosis symptoms in this underserved patient population.
Novel Endpoint Discussions Continue
Cognition said it will continue working closely with the FDA on the analytical and statistical framework surrounding the use of the neuropsychiatric inventory as the primary endpoint for the pivotal study.
The neuropsychiatric inventory is expected to play a central role in measuring treatment effects on hallucinations, delusions and other behavioral symptoms associated with dementia with Lewy bodies psychosis.
If accepted, the endpoint would represent a novel primary measure in a registrational study for this condition.
Phase 2 Results Provide Foundation
The Phase 3 program will build on data generated from Cognition’s Phase 2 COG1201 “SHIMMER” study involving patients with mild-to-moderate dementia with Lewy bodies.
In that trial, zervimesine demonstrated improvements in psychosis symptoms compared with placebo when evaluated using the neuropsychiatric inventory.
The company recently reported additional analyses showing that treatment with zervimesine slowed the progression of hallucinations and delusions by 89% relative to placebo.
These findings have helped support the company’s decision to advance the candidate into a pivotal development program.
Additional Data Expected in July
Cognition Therapeutics plans to present further analyses from the SHIMMER trial at the Alzheimer’s Association International Conference in July.
The presentation will focus on zervimesine’s effects on the hallucination and delusion components of the neuropsychiatric inventory, providing investors and researchers with additional insight into the drug’s potential clinical benefits.
The upcoming data release is expected to be closely watched as the company continues preparing for its planned Phase 3 program and future regulatory submissions.