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

Subpopulation Efficacy Limited To One Of Two Primary Endpoints

 
• By Mandy Jackson
  
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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.

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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...

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