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Cortexyme Announces Publication of New Data Further Demonstrating the Therapeutic Potential of COR388, the Company’s Lead Investigational Medicine

-- Data in aged dogs shows oral dosing of COR388 results in target engagement, reduction of bacterial load and beneficial effects on downstream pathology

-- Lysine-gingipains from P. gulae were found in the neurons of aged dogs, paralleling the discovery of gingipains from P. gingivalis in Alzheimer’s brains

Cortexyme, Inc. (Nasdaq: CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat Alzheimer’s and other degenerative diseases, today announced the publication of new data in Pharmacology Research and Perspectives revealing further detail about the pharmacodynamics and utility of the company’s lead investigational medicine, COR388. The data provides additional evidence on the ability of COR388 to engage its target, the toxic proteases, or gingipains, released by the bacterium P. gingivalis and the closely related species P. gulae, resulting in beneficial effects on bacterial load and symptoms.

Cortexyme’s foundational research previously identified gingipains in more than 90% of Alzheimer’s disease brains studied. P. gingivalis is best known for its role as a keystone bacterium in the development of periodontal disease, and has recently been shown in animal studies to infiltrate the brain after oral infection and trigger pathology of Alzheimer’s including neurodegeneration, inflammation, beta-amyloid and tau pathology.

In this publication, researchers report that COR388 demonstrates dose-dependent gingipain target engagement in a naturally occurring P. gulae infection, including in difficult to reach bacterial biofilm niches. P. gulae is the only other bacterial species known to secrete gingipains. COR388 was efficacious in improving downstream pathology of the infection, namely gingival pocket depth, a symptom of periodontal disease which affects approximately 65 million Americans. In addition, gingipain antigens and P. gulae DNA were found in the brains of aged dogs, indicating that P. gulae can also migrate from the oral cavity to the brain in a manner similar to that seen for P. gingivalis in Alzheimer’s patients.

"Chronic periodontal disease is common in dogs and, as they age, these animals can experience cognitive decline in much the same way humans do," said Stephen Dominy, M.D., Cortexyme’s Chief Scientific Officer, Co-founder and co-author on the paper. "This research shows that natural P. gulae infection in canines provides an important model for the study of P. gingivalis infection in humans and emphasizes the ability of this infection to promote degenerative disease in different organs. It also underscores that the anti-gingipain activity of COR388 is effective at reducing bacterial load and has beneficial effects on downstream disease."

"To change the trajectory of the Alzheimer’s epidemic, we need to move upstream and target the root causes of pathology and cell death," said Casey Lynch, Cortexyme’s Chief Executive Officer, Co-founder, and Chair. "This paper adds to the growing body of evidence supporting the gingipain hypothesis, the efficacy of COR388 in multiple indications, and the design of the GAIN Trial."

View the Pharmacology Research & Perspectives paper, "Treatment of Porphyromonas gulae infection and downstream pathology in the aged dog by lysine-gingipain inhibitor COR388," here: https://bpspubs.onlinelibrary.wiley.com/doi/10.1002/prp2.562

About the GAIN Trial

The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer’s Disease) Trial is a randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating the efficacy, safety, and tolerability of COR388, Cortexyme’s investigational gingipain inhibitor, in patients with mild to moderate Alzheimer’s disease. The GAIN Trial also includes a sub-study measuring the efficacy of COR388 on symptoms of periodontal disease including gingival pocket depth. The GAIN Trial has been ongoing since the second quarter of 2019, with top-line results expected in the fourth quarter of 2021. For more information on the trial, visit www.gaintrial.com.

About Cortexyme, Inc.

Cortexyme (Nasdaq: CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer’s disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer’s patients and tied to neurodegeneration and neuroinflammation in animal models. The company’s lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer’s. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

Forward-Looking Statements

Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words. Forward-looking statements are based on Cortexyme’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the final prospectus related to Cortexyme’s initial public offering filed with the Securities and Exchange Commission on May 9, 2019 and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2019. Forward-looking statements contained in this press release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200130005473/en/

Contacts

Hal Mackins
For Cortexyme, Inc.
hal@torchcomllc.com
(415) 994-0040