Cortexyme Announces Preclinical Data Demonstrating Efficacy of COR803 for the Treatment of Coronavirus Infections

Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company focused on advancing therapeutics for rare and degenerative diseases, today announced new preclinical data demonstrating the efficacy of the company’s 3CLpro inhibitor, COR803, for treatment of coronavirus infections, including COVID-19 disease, caused by SARS-CoV-2 infection. In ongoing preclinical research, COR803 successfully reduced viral load of SARS-CoV-2 in vivo after oral treatment.

COR803 is a novel 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. Key findings from the company’s latest mouse study of COR803 included:

• A decrease of virus titer in lung tissue after four days of treatment compared to vehicle control;
• Comparable efficacy in animals orally dosed twice daily vs dosed once daily; and
• Decreased lung weights in COR803 treated versus vehicle-treated animals, indicating improved pathology. Histopathological analysis is ongoing.

The target of COR803 is highly conserved across coronavirus strains observed to date and, therefore, has the potential to address both current and future coronavirus infection. Cortexyme believes COR803 has beneficial properties over other COVID-19 therapeutics and 3CLpro inhibitors in development, including:

• A chemical reaction that leads to covalent irreversible binding of the viral 3CLpro enzyme;
• High potency: Antiviral EC90 of 12 nM in human lung cell viral replication assays;
• Broad spectrum activity against multiple coronaviruses;
• Highly selective for 3CLpro versus other cellular proteases, including Cathepsin L; and
• Excellent systemic exposure in preclinical models utilizing oral, intranasal or subcutaneous administration, allowing for clinical use in multiple settings, such as outpatient and inpatient.

Cortexyme is currently in IND-enabling preclinical studies for COR803 and plans to explore partnership and licensing opportunities to support the future development of COR803.

About Cortexyme

Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage biopharmaceutical company focused on advancing therapeutics for rare and degenerative diseases. The company’s innovative pipeline includes a precision bone growth molecule and drug-targeting platform to treat rare skeletal diseases, bone cancer and injury, in addition to small molecule therapeutics targeting the infectious pathogen P. gingivalis’ role in degenerative disease progression, including for indications such as periodontal disease, oral potentially malignant disorders, and Alzheimer’s disease, among others. 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 “plan,” “potential,” “will,” “believe,” or other similar words. Examples of forward-looking statements include, among others; the potential therapeutic benefits, safety and efficacy of the company’s product candidates, including COR803, and partnership and licensing opportunities to support future development of COR803. 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 10, 2022, 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.

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