Cortexyme Announces Lead 3CLpro Inhibitor for the Treatment of Coronavirus Infection

Rhea-AI Summary

Cortexyme, Inc. (Nasdaq: CRTX) announced the selection of its lead 3CLpro inhibitor, COR803, aimed at treating coronavirus infections, including COVID-19. This decision follows the growing clinical need for effective coronavirus therapies. With an EC90 of 30 nM, COR803 demonstrates high potency and selective binding, suggesting potential for outpatient and inpatient use. The company is also progressing in its pivotal GAIN Trial for Alzheimer’s disease, with top-line data expected in the fourth quarter of 2021, showcasing its commitment to addressing significant unmet medical needs.

Positive

• COR803 shows high potency with an EC90 of 30 nM in human lung cell assays.
• The drug has selective binding to the 3CLpro enzyme, suggesting lower risk of off-target effects.
• COR803 is designed for multiple administration routes, allowing flexibility in treatment settings.
• Cortexyme's ongoing GAIN Trial for Alzheimer's is set to provide top-line data in Q4 2021, indicating progress in the pipeline.

Negative

• The company faces substantial risks and uncertainties associated with clinical trials.
• Forward-looking statements indicate potential challenges in regulatory approvals and market acceptance.

Cortexyme, Inc. (Nasdaq: CRTX), a company advancing a pivotal trial in Alzheimer’s disease with top-line data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced the selection of a lead 3CLpro inhibitor (COR803) for treatment of coronavirus infections, including COVID-19 disease, caused by SARS-CoV-2 infection.

“There continues to be a large unmet need for coronavirus treatment. The target of COR803 is highly conserved across variants and among coronaviruses in general, therefore it is expected to address both current and future coronavirus strains, including the delta variant of SARS-CoV-2,” said Casey Lynch, Cortexyme’s chief executive officer, co-founder, and chair. “We have selected COR803 based on compelling data to support its development as a potential therapy that could be prescribed at the first sign of infection or after known exposures without requiring patients to be hospitalized, as well as for those in critical care. The novel characteristics of COR803 reflect the breadth and capabilities of our proprietary research and development as Cortexyme continues to apply our innovative science to areas of high clinical need.”

COR803 is a novel patent-pending small molecule 3CLpro inhibitor discovered and developed by Cortexyme based on its expertise in cysteine protease inhibition. 3CLpro, or Mpro, is a validated antiviral drug target shown to be essential in viral replication of SARS-CoV-2. COR803 has beneficial properties over other COVID-19 therapeutics and 3CLpro inhibitors in development including:

• Covalent irreversible binding of the viral 3CLpro enzyme;
• High potency: Antiviral EC90 of 30 nM in human lung cell viral replication assays;
• Highly selective for 3CLpro versus other cellular proteases including Cathepsin L; and
• Excellent systemic exposure utilizing intranasal or subcutaneous administration, allowing for clinical use in multiple settings such as outpatient and inpatient.

About Cortexyme

Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches designed to improve the lives of patients diagnosed with Alzheimer’s and other degenerative diseases. The company is advancing its disease-modifying pivotal GAIN Trial in mild to moderate Alzheimer's disease with top-line data expected in the fourth quarter of 2021, in addition to growing a proprietary pipeline of first-in-class small molecule therapeutics for Parkinson’s disease, periodontitis, and other diseases with high unmet clinical need. Cortexyme’s lead program targets a specific, infectious pathogen called P. gingivalis found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. The company’s causation evidence for Alzheimer’s disease and the mechanism of its novel therapeutic has been independently replicated and confirmed by multiple laboratories around the world, as well as published in peer-reviewed scientific journals. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

Forward-Looking Statements

Statements in this news release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this news 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. Examples of forward-looking statements include, among others, statements we make regarding our business plans, strategy, timeline, prospects, and milestone expectations; the characteristics and potential benefits of COR803, including for the treatment of coronavirus infections, the timing and success of the company’s clinical trials and related data; the potential of atuzaginstat to treat Alzheimer’s disease, periodontal disease, and other potential indications; the timing of announcements and updates relating to its clinical trials and related data; the potential therapeutic benefits, safety and efficacy of the company’s product candidate or library of compounds; and statements about its ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to the company’s drug product candidate. Forward-looking statements are based on Cortexyme’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. 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 Cortexyme’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2021, its Quarterly Report on Form 10-Q filed with the SEC on May 6, 2021, and other reports as filed with the SEC. Forward-looking statements contained in this news 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/20210723005073/en/

FAQ

What is COR803 and how does it relate to COVID-19?

COR803 is a lead 3CLpro inhibitor developed by Cortexyme for treating coronavirus infections, including COVID-19.

When will Cortexyme announce data from the GAIN Trial for Alzheimer's?

Cortexyme expects to release top-line data from the GAIN Trial in the fourth quarter of 2021.

What are the benefits of COR803 compared to other COVID-19 treatments?

COR803 offers high potency, selective binding, and various administration methods, potentially enhancing its use in clinical settings.

What risks does Cortexyme face regarding its clinical trials?

Cortexyme faces risks that could affect the timing, success, and regulatory approval of its clinical trials and therapies.

How does COR803 target coronavirus variants?

COR803 targets a highly conserved enzyme, making it potentially effective against current and future coronavirus strains, including variants.