- Cortexyme Inc CRTX has presented additional data from its Phase 2/3 GAIN Trial at the Clinical Trials on Alzheimer's Disease Conference.
- The 643-participant 48-week GAIN Trial failed to meet statistical significance on its co-primary cognitive and functional endpoints in the overall cohort.
- But, the study data showed that treatment with atuzaginstat slowed decline compared to placebo on most clinical endpoints in prespecified populations selected based on P. gingivalis infection markers.
- The results showed that the 40 mg BID arm demonstrated equivalent or better efficacy across key endpoints than the higher dose, 80 mg BID, and a superior safety profile.
- Across critical safety measures, the 40 mg BID treatment arm rates were either comparable to placebo or substantially better than in the 80 mg BID arm.
- Atuzaginstat was associated with dose-related liver enzyme elevations - 2% on placebo, 7% on 40 mg BID, and 15% on 80 mg BID.
- The Company said that these elevations alone were not clinically significant, and virtually all participants were asymptomatic.
- Price Action: CRTX shares are down 15.80% at $13.26 during the market session on the last check Thursday.
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