CRTX - Cortexyme Announces the Initiation of an Open-Label Extension Study for the GAIN Trial of COR388 in Alzheimer's Disease

Cortexyme, Inc. (Nasdaq: CRTX), 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 and other degenerative diseases, today announced it is initiating an open-label extension study in the United States for its Phase 2/3 GAIN Trial of COR388 in subjects with mild to moderate Alzheimer’s disease (AD). Additionally, the GAIN Trial Data Monitoring Committee recently completed its first planned safety review and recommended continuation of the study as planned.

“We are pleased to begin an open-label extension study of COR388 and, in doing so, facilitate the opportunity for subjects in the GAIN Trial to continue to participate in research directed at bringing forward a new potential therapeutic option for Alzheimer’s disease,” said Michael Detke, M.D., Ph.D., Cortexyme’s Chief Medical Officer. “We anticipate that the open-label extension of the GAIN Trial will supply valuable data on the safety and clinical activity of COR388 in a larger population of patients, for a longer period of time, and will allow subjects randomized to placebo in the GAIN Trial the opportunity to experience treatment with COR388.”

The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer’s Disease) Trial is based on a growing body of scientific evidence showing that the pathogen Porphyromonas gingivalis, or P. gingivalis, most commonly associated with chronic periodontal disease, and its secreted proteases called gingipains can infiltrate the brain and cause AD. The randomized, double-blind, placebo-controlled trial is evaluating the efficacy, safety, and tolerability of COR388, Cortexyme’s investigational gingipain inhibitor, in patients with mild to moderate AD. The GAIN Trial has been ongoing since the second quarter of 2019, with top-line results expected in the fourth quarter of 2021.

Upon completing the 48-week placebo-controlled period of the GAIN Trial, participants in the United States may be eligible to enroll in the open-label extension study, where they will receive COR388 for an additional 48 weeks. During the open-label extension study, safety will be monitored and additional assessments including cognitive tests will be performed. In Phase 1a/1b testing, Cortexyme previously reported favorable safety, tolerability and pharmacokinetics as well as positive biomarker results demonstrating positive trends in patients with AD.

For more information on the GAIN 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.

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