Cognition Therapeutics (NASDAQ: CGTX) has reported positive interim results from its Phase 2 MAGNIFY trial investigating oral zervimesine (CT1812) in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration. The masked futility analysis revealed that patients receiving zervimesine for at least six months experienced slower lesion growth compared to those on placebo.
The analysis, conducted on data from 57 participants, marks another success in zervimesine's growing portfolio of positive clinical outcomes across multiple central nervous system disorders. The study has enrolled 100 participants total, with final visits concluding in February 2025 and complete analysis expected in the second quarter.
Strong Performance Across Multiple Indications
Zervimesine's success extends beyond geographic atrophy. In December 2024, the Phase 2 SHIMMER study in mild-to-moderate dementia with Lewy bodies (DLB) met its primary safety and tolerability endpoints while demonstrating remarkable efficacy. Patients receiving zervimesine showed:
- 86% improvement in neuropsychiatric inventory scores
- 52% better performance in activities of daily living
- 91% improvement in clinician's assessment of fluctuations
- 62% enhancement in motor function, including gait, balance, and tremor
The drug's potential in Alzheimer's disease was similarly impressive, with the Phase 2 SHINE study showing a 95% reduction in cognitive decline as measured by ADAS-Cog 11 in a biomarker-defined subgroup.
Novel Mechanism Targeting Multiple Pathways
Zervimesine's broad therapeutic potential stems from its innovative mechanism of action through the sigma-2 receptor. This approach targets the toxic effects of protein accumulation - including both amyloid-β and α-synuclein - that characterize various neurodegenerative conditions. The once-daily oral medication aims to interrupt these pathological processes, potentially slowing disease progression and improving patient outcomes.
Strategic Development Plans
Cognition Therapeutics plans to meet with the FDA for end-of-Phase 2 discussions regarding both Alzheimer's disease and DLB programs. These meetings will focus on designing registrational studies for these indications, building on the strong efficacy signals observed across multiple trials.
"The consistent positive results across different neurodegenerative conditions suggest zervimesine may offer a versatile approach to treating various CNS disorders," said the company in its statement. The completion of the MAGNIFY study was strategically timed to preserve capital resources, which will be redirected toward advancing other promising indications in the pipeline.
