Therapy Areas: Central Nervous System
Cortexyme Completes Phase 1 Single and Multiple Ascending Dose Clinical Trial of COR588
27 July 2022 - - US-based clinical-stage biopharmaceutical company Cortexyme, Inc. (NASDAQ: CRTX) has successfully completed its Phase 1 single ascending dose and multiple ascending dose (SAD/MAD) clinical trial of COR588, the company's lysine gingipain inhibitor in development for the treatment of Alzheimer's disease and indications with disease pathology associated with the keystone pathogen P. gingivalis, the company said.

The study was a randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of COR588 in healthy adult participants.

Previously announced in March 2022, the SAD portion of the Phase 1 clinical trial demonstrated that COR588 was well-tolerated across all cohorts in the dose range from 25 mg to 200 mg with no serious adverse events.

No clinically significant findings were observed on safety measures, including vital signs, laboratory findings, telemetry, or ECGs.

No clinical chemistry or hematology safety concerns were observed at any dose.

Additionally, COR588 exhibited an 11-to-12-hour half-life consistent with once daily dosing and a dose-proportional pharmacokinetic profile that importantly achieved the targeted exposure predicted for therapeutic efficacy.

The MAD portion of the Phase 1 clinical trial of COR588 demonstrated that once daily oral administration of COR588 over a 10-day period was well-tolerated across all cohorts in the dose range from 50 mg to 200 mg with no serious adverse events observed.

High central nervous system penetration of COR588 was confirmed after 10 days of administration.

Cortexyme will provide an update on the development path forward for COR588 in conjunction with its planned corporate name change to Quince Therapeutics and detailed go-forward growth strategy that is expected to be announced on August 1, 2022.

COR588 is a selective, oral small-molecule inhibitor of lysine gingipains, protease virulence factors secreted by P. gingivalis, and is being developed for the potential treatment of patients with Alzheimer's disease.

Sponsored by Cortexyme, the COR588 Phase 1 clinical trial (Identifier: NCT04920903) was 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 participants.

Cortexyme, Inc. (NASDAQ: CRTX) is a clinical stage biopharmaceutical company focused on advancing therapeutics for rare and degenerative diseases.
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