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The pre-specified subgroup of participants with P. gingivalis DNA detectable in saliva at baseline (PG-DS n=242) showed a dose response, with a 57% slowing of cognitive decline as measured by ADAS-Cog11 in the 80 mg BID arm (p=0.02) and a 42% slowing in the 40 mg BID arm (p=0.07) vs. Significant benefits in this subgroup were not seen on the other co-primary, ADCS-ADL. The cognitive benefit of atuzaginstat in patients with high P. gingivalis infection was reinforced by similar results in multiple pre-specified infection related subgroups and with multiple methods of analysis. gingivalis in saliva at week 24 were significantly correlated with improved outcomes at the end of the treatment period as measured by ADAS-Cog11 (p=0.0007), Clinical Dementia Rating–Sum of Boxes (CDR) (p=0.004), Mini-Mental State Exam (MMSE) (p=0.007), and a beneficial trend on ADCS-ADL (p=0.08). The sub-study in periodontal disease demonstrated a trend to benefit on the primary clinical endpoint of pocket depth in the same pre-specified sub-group with P. Further results will inform the next stage of development in periodontitis and will be presented at a future scientific conference. “Today marks a major milestone toward a comprehensive understanding of Alzheimer’s and slowing of disease progression. The evidence from the GAIN Trial advances our ability to identify the right patients, impact an upstream target, and improve patient outcomes,” said Casey Lynch, Cortexyme’s chief executive officer, co-founder, and chair. “We are focused on next steps to advance this breakthrough treatment for the benefit of patients and their families.” ALTERNATIVES TO JST GAIN REDUCTION TRIAL Most adverse events were mild to moderate in severity. The most common were gastrointestinal, such as diarrhea in up to 16% and nausea in 6% of participants treated with atuzaginstat vs. 3% and 2% of placebo participants, respectively. Atuzaginstat was associated with dose-related liver enzyme elevations >3X the upper limit of normal: 2% on placebo, 7% on 40 mg BID, and 15% on 80 mg BID. These elevations alone were not clinically significant, and virtually all participants were asymptomatic. Two participants in the 80 mg BID arm had concomitant bilirubin elevations without alternative explanation. ALTERNATIVES TO JST GAIN REDUCTION TRIAL. "Licensed Entity" is the individual, company, or legal entity purchasing this License (hereinafter "Licensed Entity" or "you"). "Font Software" is digital software that generates typeface and/or illustration designs when used with computers and other software (hereinafter "Font Software" or "Font"). If you have purchased a License to use the Font Software in a sealed retail package and do not agree to the terms of this Agreement, return it unopened to the place of purchase for a full refund. If you do not agree to the terms of this Agreement, do not purchase this License, download, install, and access or use the Font Software. By downloading the Font Software or opening the package, installing, copying, accessing or otherwise using the Font Software, you agree to be bound by the terms of this Agreement. (hereinafter, "FONTHAUS") for the product, designs and software that accompany this Agreement, and is also applicable to any media, printed materials, electronic documentation, updates, add-ons, Web services and any other material that may be associated with the product now or in the future. This End User License Agreement (hereinafter, "EULA," "License," "Agreement" or "License Agreement") is a legal agreement between you and DsgnHaus, Inc. 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