Cortexyme Provides Regulatory Update for COR388 Development Program in Alzheimer’s Disease

Cortexyme, Inc. (Nasdaq: CRTX) today provided an update on its clinical development plans for COR388, the company’s lead investigational medicine in development for mild to moderate Alzheimer’s disease (AD). The company conducted a Type C meeting with the FDA gathering agreement and feedback on development plans through NDA, including the Phase 2/3 GAIN Trial statistical analysis plan, metabolite characterization, nonclinical studies, population pharmacokinetics, and drug-drug interaction studies.

Following discussion with the FDA, the company intends to conduct an interim analysis for overwhelming efficacy in the ongoing GAIN Trial. The analysis, currently planned before year-end 2020, will be conducted after approximately 100 patients in each of the GAIN Trial’s three arms complete six months of treatment. The co-primary endpoints for the interim analysis will be change from baseline in ADAS-Cog11 and CDR-SB versus placebo.

“Cortexyme is pleased with the collaborative and productive dialogue with the FDA’s Division of Neurology Products,” said Michael Detke, M.D., Ph.D., Cortexyme’s Chief Medical Officer. “With COR388, we are pursuing a differentiated mechanism of action that targets the gingipains, or toxic proteases, released by the bacterium P. gingivalis, which we believe infects the brain and causes Alzheimer’s pathology. The body of preclinical and clinical evidence generated to date suggests COR388 could have a favorable impact on inflammation, neurodegeneration, bacterial load of P. gingivalis, and cognitive testing.”

Cortexyme continues to expect the GAIN Trial’s final analysis in the fourth quarter of 2021. The co-primary endpoints will be change from baseline in ADAS-Cog11 and CDR-SB versus placebo. The GAIN Trial is 90% powered to meet statistical significance on both primary endpoints with the planned 570 randomized patients. Additional exploratory endpoints include other cognitive, functional and clinical outcomes, safety and tolerability measures, and biomarkers relating to P. gingivalis infection, as well as traditional AD biomarkers and brain volume measurements. The study is stratified for both AD severity (mild versus moderate) and ApoE4 carriers versus non-carriers.