SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cortexyme, Inc. (Nasdaq: CRTX), today announced that its work to pioneer a novel disease-modifying therapeutic approach to treat a key underlying cause of Alzheimer’s and other degenerative diseases will be discussed in two research abstracts at the Alzheimer’s Association International Conference® 2019 (AAIC®). The conference, which is the largest international meeting dedicated to advancing dementia science, will be held July 14-18, 2019 in Los Angeles.
In a Developing Topics poster (P4-663), researchers will detail the rationale for and design of the GAIN trial, the recently initiated Phase 2/3 study of Cortexyme’s lead gingipain inhibitor, COR388, in subjects with mild to moderate Alzheimer’s disease (AD). The GAIN trial is based on growing evidence that points to a key role for Porphyromonas gingivalis, the bacterium most commonly associated with chronic periodontal disease, in the development of AD, based on the identification of the bacteria in the brain of AD patients and its ability to cause neurodegeneration, inflammation, and other pathology associated with Alzheimer’s in animal models.
“We’re in a critical moment for Alzheimer’s drug development, and patients deserve new approaches driven by solid science,” said Casey Lynch, Cortexyme’s chief executive officer, chair, and co-founder. “The researchers at Cortexyme, along with our academic and industry collaborators, look forward to the opportunity to share the latest updates on our work to evaluate the gingipain hypothesis, which represents a wholly new, potentially disease-modifying approach to a disease that affects millions of patients and their families globally.”
A second Developing Topics poster (P4-542) will examine the utility of a speech-based digital biomarker for tracking disease progression and treatment response to COR388. This tool, developed by Winterlight Labs, was deployed in Cortexyme’s Phase 1b clinical trial of COR388 and is also being used as an exploratory endpoint in the GAIN trial.
The schedule of Cortexyme-related presentations expected at the meeting is as follows:
[Abstract P4-663]: “Initiation of the Phase 2/3 GAIN trial of COR388, a novel bacterial virulence factor inhibitor for the treatment of Alzheimer’s Disease (AD) based on Phase 1 a/b safety, PK, biomarker and efficacy data”
Mike Detke, M.D., Ph.D., et al.
Session: Developing Topics – Poster Presentations
Poster presented Wed., July 17, 2019, 9:30am - 4:15pm, South Hall GH and discussed during AAIC press briefing earlier on that same day
[Abstract P4-542] “Utility of speech-based digital biomarkers for evaluating disease progression in clinical trials of Alzheimer's disease”
William Simpson, Ph.D., et al.
Session: Developing Topics – Poster Presentations
Poster presented Wed., July 17, 2019, 9:30am - 4:15pm, South Hall GH
About Cortexyme, Inc.
Cortexyme (Nasdaq: CRTX) is a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat 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 disease. More information about the trial can be found at www.GAINtrial.com. To learn more about Cortexyme, visit www.cortexyme.com.
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 June 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.
