- Cortexyme (NASDAQ:CRTX) tanks 24% premarket after receiving a letter from the FDA stating that a partial clinical hold has been placed on atuzaginstat (COR388) impacting the open-label extension (OLE) phase of the company’s Phase 2/3 study, the GAIN Trial (GingipAIN Inhibitor for Treatment of Alzheimer’s Disease).
- 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.
- Under the partial clinical hold, recruitment is suspended but current participants may continue treatment.
- Participants in the fully enrolled (N=643) double-blind, placebo-controlled phase of the GAIN Trial will continue to receive study drug at their assigned dose, with top-line results in Q4.
- Cortexyme will continue to collaborate with the FDA on the overall development program for atuzaginstat.