Late-stage study of Cortexyme's Alzheimer's med atuzaginstat passes interim tollgate

 

• Cortexyme (NASDAQ:CRTX) announces that, following an interim analysis by the independent Data Monitoring Committee (DMC), the Phase 2/3 clinical trial, GAIN, evaluating lead candidate atuzaginstat (COR388) in patients with mild-to-moderate Alzheimer's disease (AD) will continue unmodified to the one-year time point.
• The DMC's analysis was based on 300 participants who had reached six months of treatment.
• Topline data from the fully enrolled population of 643 subjects should be available in a year. The co-primary endpoints are the changes from baseline to week 48 in two AD scales called ADAS-Cog 11 and ADCS-ADL versus placebo. Secondary endpoints include additional efficacy measures.
• Atuzaginstat targets toxic protease enzymes, or gingipains, produced by a bacterium called Porphyromonas gingivalis (P. gingivalis), an oral pathogen that causes gum disease. The bacterium releases gingipains when it invades the brain. Results from nerve cell cultures showed that atuzaginstat and proprietary gingipain inhibitors protected neurons infected with the bacterium from synapse loss while reducing bacterial load in infected neurons, astrocytes and microglia and protecting against deficits in other pathways impacted by the pathogen.
• Management hosts a conference call this morning at 8:30 am ET to discuss the tollgate. 
• https://seekingalpha.com/news/3641654-late-stage-study-of-cortexymes-alzheimers-med-atuzaginstat-passes-interim-tollgate