Cortexyme: Partial Hold on Development Program for Atuzaginstat in Alzheimer’s

 Cortexyme, Inc. (NASDAQ: CRTX), a clinical-stage biopharmaceutical company focused on Alzheimer’s and other degenerative diseases, received a letter from the U.S. Food and Drug Administration (FDA) stating that a partial clinical hold has been placed on atuzaginstat (COR388) impacting the open-label extension (OLE) phase of the company’s ongoing Phase 2/3 study, the GAIN Trial. Under the hold, no new participants will be enrolled in the OLE and currently enrolled OLE participants will be discontinued. Participants in the fully enrolled (N=643) double-blind, placebo-controlled randomized phase of the GAIN Trial will continue to receive study drug at their assigned dose, with top-line results from the double-blind GAIN Trial in Q4 2021.

The partial clinical hold was initiated following the review of hepatic adverse events in the atuzaginstat trial by the FDA. These events have been reversible and without any known long-term adverse effects for the participants. Cortexyme will continue to collaborate with the FDA on the overall development program for atuzaginstat.

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