8 September 2021 - - The first cohort of healthy participants have been dosed in the Phase 1 clinical trial of US-based Cortexyme, Inc's (NASDAQ: CRTX) new drug candidate, COR588, the company said.

COR588 is a second-generation small-molecule lysine-gingipain inhibitor differentiated from the company's lead drug candidate atuzaginstat (COR388) by its improved pharmacokinetic properties and anticipated once daily oral administration.

Delivering on its commitment to bring innovation to high unmet clinical needs, Cortexyme expects COR588 to be targeted for use in the treatment of periodontal disease and other P. gingivalis-related indications.

Sponsored by Cortexyme, the COR588 Phase 1 trial is a randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of oral COR588 capsules in healthy adult patients.

The trial will enroll up to 64 participants and is listed under clinicaltrials.gov Identifier: NCT04920903.

Future studies will evaluate the ability of COR588, an oral investigational medicine, to slow or halt the progression of periodontal disease, among other potential indications, by inactivating the toxic proteases, or gingipains, released by the keystone bacterium P. gingivalis.

Periodontal disease represents a major unmet medical need impacting 65 m Americans. Therapeutic effects of gingipain inhibitors have been demonstrated in both mouse and naturally occurring aged dog models (Arastu-Kapur et al, 2020).

Cortexyme is evaluating the efficacy of its lead lysine-gingipain inhibitor, atuzaginstat, in the company's pivotal GAIN Trial evaluating the role of P. gingivalis in the progression of Alzheimer's disease in mild to moderate patients, which includes a 233-patient sub-study in periodontal disease called REPAIR (REduction of P. GingivAlIs to ImpRove Pocket Depth). Top-line data from the GAIN Trial and REPAIR sub-study are expected by mid-November 2021.

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 by mid-November 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.