Cortexyme Advances COR388 Clinical Development Program in Alzheimer’s Disease After FDA Meeting

Cortexyme Advances COR388 Clinical Development Program in Alzheimer’s Disease After FDA Meeting
Following feedback from the U.S. Food and Drug Administration (FDA), Cortexyme will conduct an interim analysis for effectiveness of its lead investigational therapy COR388, currently in the Phase 2/3 GAIN trial for treatment of mild to moderate Alzheimer’s disease. The analysis, expected to be finished by the end of 2020, will help guide the company through a New Drug Application procedure with the FDA. The GAIN trial (NCT03823404) — still enrolling at numerous sites in the U.S. and Europe — is assessing the efficacy, safety, and tolerability of two oral doses (80 mg or 40 mg pills, twice a day) of COR388 versus placebo, in patients with a clinical diagnosis of mild to moderate Alzheimer's. COR388 is a novel bacterial protease inhibitor designed to target a specific bacteria, Porphyromonas gingivalis (P. gingivalis), which has been identified in the brain tissue and cerebrospinal fluid of Alzheimer’s patients. P. gingivalis produces toxic enzymes known as gingipains, which can mediate the toxicity of P. gingivalis in different cells. Blocking gingipains decreases the bacteria’s ability to cause disease. COR388 inhibits these gingipains. The investigational
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