Cortexyme (NASDAQ:CRTX) announces that it has enrolled 500 subjects in its Phase 2/3 GAIN study evaluating lead candidate atuzaginstat (COR388) in patients with mild-to-moderate Alzheimer’s disease.
An interim analysis, expected to happen before year-end, will be conducted when 300 participants reach 24 weeks of treatment. Topline results from the completed study should be available in Q4 2021.
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.
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