Gum Disease Bacteria Found in Most Alzheimer’s Patients in Atuzaginstat Trial

Gum Disease Bacteria Found in Most Alzheimer’s Patients in Atuzaginstat Trial
Most of the mild to moderate Alzheimer’s patients enrolled in the atuzaginstat (COR388) Phase 2/3 trial show evidence of systemic infection due to Porphyromonas gingivalis, a bacteria linked to periodontal disease whose toxic enzymes are thought to contribute to Alzheimer's and are targets for this candidate therapy. A "high proportion" also test positive for biomarkers associated with this neurodegenerative disease. As such, these adults have a profile that supports a response to atuzaginstat's use in the ongoing GAIN study (NCT03823404), its developer, Cortexyme, announced in a press release. “The baseline biomarker and P. gingivalis characteristics reported today give us confidence that we have enrolled an appropriate patient population for testing the efficacy of atuzaginstat in the GAIN Trial,” said Michael Detke, MD, PhD, chief medical officer for Cortexyme. Data was presented during the oral session “Phase 2/3 GAIN trial of COR388 (atuzaginstat), a novel bacterial virulence factor inhibitor for the treatment of Alzheimer’s disease: Update and baseline Data,” at the 13th Clinical Trials on Alzheimer's Disease Conference (CTAD), held online Nov. 4–7. Atuzaginstat is a small molecule inhibitor of gingipains, the enzymes produced and released by P. gingivalis that have been found in more than 90% of post-mortem patient brain samples. These toxic enzymes are also known to trigger Alzheimer’s in animal models. By block these enzymes, which are also thought to contribute to disease progression, atuzaginstat may be able to slow, or stop, the continuous neurodegeneration observed in patients. GAIN, a Phase 2/3 trial, is assessing the safety, tolerability, and efficacy of two doses of oral atuzaginstat — 80 or 40 mg capsules tak
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