Cognition Therapeutics receives FDA alignment on pivotal trial design for zervimesine in DLB psychosis

COGNITION THERAPEUTICS INC

• FDA agreed that DLB psychosis is an approvable outcome; key aspects of Phase 3 trial design aligned.
• Phase 3 study expected to start mid-2027; enrollment of DLB patients with psychosis, randomized to 100 mg zervimesine or placebo for 9 months.
• Company to use NPI as novel primary endpoint; FDA will collaborate on analytical and statistical details.
• Phase 2 SHIMMER trial showed zervimesine slowed progression of hallucinations and delusions by 89% vs placebo.
• No approved treatments for DLB psychosis; current off-label antipsychotics are considered potentially dangerous.