The FDA has placed a clinical hold on Cortexyme Inc's (NASDAQ:CRTX) atuzaginstat (COR388) Investigational New Drug application (IND 134303).
- The Company plans to provide additional updates pending continued engagement with FDA.
- Cortexyme is immediately implementing a cost reduction program to rationalize operations, providing an expected cash runway through 2024.
- Related content: Benzinga's Full FDA Calendar.
- The Company intends to prioritize the development of its next-generation gingipain inhibitor, COR588, in Alzheimer's disease.
- COR588 is currently completing a Phase 1 SAD/MAD study, and results are expected in Q2 of 2022.
- In addition, Cortexyme plans to explore strategic alternatives for its coronavirus program and non-Alzheimer's indications for COR388.
- In November last year, the Company presented data from Phase 2/3 GAIN Trial of atuzaginstat in Alzheimer's Disease.
- The 643-participant 48-week trial failed to meet statistical significance on its co-primary cognitive and functional endpoints in the overall cohort.
- Price Action: CRTX shares are down 34.0% at $5.98 during the premarket session on the last check Wednesday.
