Cortexyme is also currently recruiting eight older healthy adu
COR388, Cortexyme's investigational compound to treat Alzheimer’s, was safe and well-tolerated in healthy volunteers taking part in a Phase 1 clinical trial, the company announced. COR388 is a first-in-class bacterial protease inhibitor designed to target a specific bacteria that has been identified in both the brain tissue and cerebrospinal fluid of Alzheimer’s patients. Stephen Dominy, MD, Cortexyme’s co-founder and chief scientific officer, has discovered that Alzheimer’s symptoms and pathology are triggered by the presence of this particular pathogen, which has not been disclosed. Broad-spectrum antibiotics are unable to target this bacteria, and the use of COR338 was seen in early testing to rescue neurons from bacterial toxicity, potentially preventing further cognitive decline in patients. Cortexyme announced the successful completion of its placebo-controlled, single-ascending dose Phase 1 trial (NCT03331900) in 34 healthy volunteers. The trial was the first of COR388’s clinical development plan and was designed to assess its safety, tolerability, and pharmacokinetics (the movement of drug into, through, and out of the body; essentially how the body affects a drug). COR388 was found to be safe and well-tolerated by volunteers, ages 20 to 70. The small molecule produced a favorable pharmacokinetic profile and tissue distribution when given orally in different doses. The company plans to open a Phase 2 proof of efficacy study in Alzheimer's patients in 2019.