Cortexyme switches direction, announces layoffs after FDA slaps hold on dark horse Alzheimer’s candidate
Cortexyme’s efforts to develop an outside-the-box treatment for Alzheimer’s took a significant hit Tuesday.
The biotech announced the FDA has put a full clinical hold on their lead drug for the disease. The agency had already shuttered one trial for the candidate after the company reported elevated signs of liver damage in volunteers.
As a result, Cortexyme announced that it’s changing course and will move forward with a different, next-generation molecule now in Phase I. The decision is a marked departure from the company’s posture just two months ago when executives announced they would allay safety concerns from regulators and outside Alzheimer’s experts by simply using a lower dose of the drug.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 157,800+ biopharma pros reading Endpoints daily — and it's free.