Cortexyme (CRTX) Announces Clinical Hold on Atuzaginstat's Investigational New Drug Application

Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company focused on Alzheimer’s and other degenerative diseases, today announced that the company received a letter from the U.S. Food and Drug Administration (FDA) on January 25, 2022 placing a full clinical hold on atuzaginstat’s (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 and to allow continued support for planned clinical milestones, providing an expected cash runway through 2024. The company intends to prioritize 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 the second quarter 2022. In addition, Cortexyme plans to explore strategic alternatives for its coronavirus program and non-Alzheimer’s indications for COR388. Cortexyme intends to provide a more detailed update on its pipeline and anticipated milestones for 2022 in the near future.

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