Cortexyme Hit With Clinical Hold Over Experimental Alzheimer’s Drug

The FDA has placed a full clinical hold on Cortexyme’s investigational Alzheimer’s drug atuzaginstat (COR388) — an oral protease inhibitor targeting gingipains, toxic enzymes from bacteria discovered in the brains of patients with the disease.

The company did not disclose the reason for the hold but said it would provide further updates following more engagement with the FDA.

The company said it will prioritize development of another gingipain inhibitor for treating Alzheimer’s, COR588. The candidate is being evaluated in an ongoing phase 1 trial and results will be available during the second quarter of this year.

The San Francisco, Calif., drugmaker also said it plans to pursue nonAlzheimer’s indications for atuzaginstat.