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Cortexyme Alzheimer’s Study Fails; Drug Slows Cognitive Decline In Some Patients

Subpopulation Efficacy Limited To One Of Two Primary Endpoints

 
• By Mandy Jackson

Atuzaginstat targets a bacteria associated with Alzheimer’s disease. The higher of two doses showed a 57% slowing in cognitive decline in the Phase II/III GAIN trial in mild to moderate patients with P. gingivalis infection confirmed by saliva test.

Handrawn illustration of human brain on light grey background
Atuzaginstat inhibits gingipains created by P. gingivalis in the brain • Source: Alamy

Cortexyme, Inc.’s drug atuzaginstat did not meet either of the two primary endpoints in the Phase II/III GAIN clinical trial that enrolled 643 patients with mild to moderate Alzheimer’s disease. However, the company said when it revealed top-line results on 26 October that the drug did slow cognitive decline by up to 57% in a patient subgroup that aligns with the biologically relevant population for atuzaginstat.

South San Francisco-based Cortexyme’s value surged in the aftermath of US Food and Drug Administration accelerated approval in June for Biogen, Inc./Eisai Co., Ltd.’s Aduhelm (aducanumab) based on biomarker results – the antibody’s ability to clear amyloid-beta plaques from the brains of patients with mild Alzheimer’s disease

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