Cortexyme Stops Enrollment In Mid-Stage Atuzaginstat Study In Alzheimer's Disease

Following the review of hepatic adverse events, the FDA has instituted a partial clinical hold impacting the open-label extension (OLE) phase of Phase 2/3 GAIN trial of Cortexyme Inc (NASDAQ: CRTX) evaluating atuzaginstat (COR388) in patients with mild to moderate Alzheimer's disease.
The adverse events were reversible and without any known long-term adverse effects for the participants.
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) GAIN Trial will continue to receive the study drug, with top-line data expected by the end of this year.
The OLE is intended to evaluate the long-term safety and efficacy measures of participants in the GAIN Trial.
Price Action: CRTX shares have tumbled 24.4% at $35.9 in the premarket session on the last check Tuesday.