Cognition Therapeutics shares rose 5% after the FDA backed key design elements of its Phase 3 trial for zervimesine in Lewy bodies dementia psychosis. The trial launching mid-2027 will randomize patients to once-daily 100 mg for nine months, with Phase 2 data showing an 89% slowdown in hallucinations and delusions.
Cognition Therapeutics received written feedback from the FDA confirming psychosis associated with dementia with Lewy bodies as an approvable indication and aligning on several key components of its pivotal Phase 3 clinical trial, including the use of the neuropsychiatric inventory as the primary efficacy endpoint.
The company plans to launch the registrational Phase 3 program in mid-2027, randomizing patients to once-daily 100 mg oral doses of zervimesine or placebo over a nine-month treatment period, with eligibility extended to individuals on stable off-label antipsychotic medications.
Results from the Phase 2 COG1201 “SHIMMER” study in mild-to-moderate dementia with Lewy bodies demonstrated zervimesine’s ability to improve psychosis symptoms and revealed an 89% slowdown in the progression of hallucinations and delusions relative to placebo, providing the cornerstone for the Phase 3 strategy.
