Cognition Therapeutics (NASDAQ: CGTX) received written feedback from the U.S. Food and Drug Administration and, according to the company, the FDA agreed that psychosis associated with dementia with Lewy bodies could be an approvable outcome and aligned on key aspects of a pivotal trial to support a New Drug Application.
The registrational program is expected to begin in mid-2027 and would enroll people with DLB who experience hallucinations and delusions; patients receiving stable background treatment with off-label antipsychotic medications would be eligible.
Following screening, participants would be randomized to receive either 100 mg once-daily oral zervimesine or placebo for nine months. The company will work with the FDA on analytical and statistical details for the use of the Neuropsychiatric Inventory as a novel primary endpoint.
The planned Phase 3 builds on findings from the Phase 2 SHIMMER study in mild-to-moderate DLB; the company claims a recent Phase 2 analysis showed zervimesine slowed progression of hallucinations and delusions by 89 percent.
The company also stated zervimesine has been generally well tolerated in prior studies and that additional Phase 2 analyses will be presented at the Alzheimer’s Association International Conference in July.
