Benzinga | Feb 16, 2021 08:52AM EST

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.