Cortexyme, Inc., a biopharmaceutical company developing therapies for patients diagnosed with degenerative diseases, announced results from the single ascending dose (SAD) portion of the Phase 1 clinical trial of its new drug candidate COR588, a next-generation, oral, small-molecule lysine gingipain inhibitor in development for the treatment of diseases related to P. gingivalis infection. The SAD trial was designed to evaluate the safety and pharmacokinetics of COR588 in healthy volunteers.
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 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. Cortexyme expects to present the full data set from the COR588 Phase 1 clinical trial in the second quarter of 2022.