Cortexyme has concluded the single ascending dose and multiple ascending dose (SAD/MAD) portions of the Phase I clinical trial of COR588 to treat Alzheimer’s disease and indications with disease pathology linked to keystone pathogen P. gingivalis.

The first-in-human, randomised, placebo-controlled, double-blind trial has been designed to analyse the safety, tolerability and pharmacokinetics of COR588 in healthy adults.

This trial, sponsored by Cortexyme, assessed single and multiple ascending doses of oral COR588 capsules.

COR588 is a selective, oral small-molecule inhibitor of lysine gingipains, protease virulence factors secreted by P. gingivalis.

According to the findings from the SAD portion of the Phase I trial, COR588 was found to be well-tolerated across all arms in doses ranging from 25mg to 200mg without any serious adverse events. 

No clinically substantial results were seen on safety measures, including laboratory findings, vital signs, telemetry, or ECGs. 

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Furthermore, no clinical chemistry or haematology safety concerns were reported at any dose. 

COR588 showed a dose-proportional pharmacokinetic profile that attained the targeted exposure projected for therapeutic efficacy, as well as an 11-to-12-hour half-life in line with once-a-day dosing.

Data from the MAD portion of the trial showed that a once-a-day oral dose of COR588 for ten days was found to be well-tolerated across all cohorts in doses ranging from 50mg to 200mg without any serious adverse events.

Following ten days of dosing, greater central nervous system penetration of COR588 was reported.

In April 2019, Cortexyme commenced a Phase II/III trial to assess its investigational drug, COR388, to treat mild to moderate Alzheimer’s disease.