Cortexyme Reports Safety and Pharmacokinetics Results from Single Ascending Dose Portion of its Phase 1 Clinical Trial of COR588
COR588 well-tolerated in all dose cohorts
Human pharmacokinetics support once daily oral dosing
Multiple ascending dose data expected in the second quarter of 2022
In the SAD portion of the Phase 1 trial, preliminary results indicate COR588 was well-tolerated across all four cohorts in the dose range from 25 mg to 200 mg with no serious adverse events. No clinically significant findings were observed on other safety measures, including vital signs, laboratory findings, telemetry, or ECGs. In the study, COR588 exhibited an 11-to-12-hour half-life consistent with once daily dosing and a dose-proportional pharmacokinetic profile that achieved and exceeded the targeted exposure predicted for therapeutic efficacy.
“COR588 was designed to be a potent and selective molecule with pharmacokinetics supportive of once daily oral dosing and these data support continued development,” said
COR588 Phase 1 Trial Overview
COR588 is a selective, oral small-molecule inhibitor of lysine gingipains, protease virulence factors secreted by P. gingivalis, and is being developed for patients with disorders related to P. gingivalis infection, including Alzheimer’s disease. The clinical trial of COR588 has now progressed to the second portion of this Phase 1 study, with a multiple ascending dose (MAD) evaluation of three cohorts: 50 mg, 100 mg, and 200 mg of COR588 versus placebo, once daily for 10 days.
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,” “will,” “may,” “should,” “estimate,” “project,” “potential,” “encouraged,” or other similar words. Examples of forward-looking statements include, among others, the strategic development path for COR588 including with regard to the Phase 1 clinical trial; its business plans, internal and external development of the pipeline, strategy, planned FDA submissions and clinical trials and timeline, prospects, and milestone expectations; the timing and success of the company’s clinical trials and related data, including plans and the ability to initiate, conduct and/or complete current and additional studies; the potential of COR588 to treat Alzheimer’s disease and other 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, further development of atuzaginstat and other programs or indications, regulatory submissions and interactions with regulators, and related response and decisions, 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