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Cortexyme presents new analyses of its GAIN Phase II/III trial for AD

Wednesday 25 August 2021

Cortexyme presents new analyses of its GAIN Phase II/III trial for ADOn 25 August, Cortexyme, a clinical-stage pharmaceutical company developing novel treatments for altering the course of Alzheimer’s disease (AD) and other neurodegenerative disorders, presented new data of its GAIN Phase II/III trial at the virtual Annual Biomarkers for Alzheimer’s Disease Summit. The GAIN Phase II/III study is a randomised, double-blind and placebo-controlled study assessing the efficacy, safety and tolerability of two dose levels (40 and 80mg) of COR388 oral capsules in people with mild to moderate Alzheimer’s disease (AD).

COR388 is an oral small-molecule inhibitor of gingipains, which are proteins that are released by bacteria species (p.gingivalis) that commonly reside in the mouth. Previous studies have shown that people with bacterial gum disease have a higher risk of developing AD and that people with AD have elevated levels of gingipain in their brains. The GAIN trial has been enrolling since the second quarter of 2019 at sites in the US and Europe and recruited 643 participants. Top-line results are expected by mid-November 2021. Analyses presented showed that approximately 84% of the participants had high levels of well-established AD biomarkers, such as amyloid-beta and tau, in their cerebrospinal fluid (CSF). All participants analysed at the beginning of the study who had CSF available data (472 participants), were positive for antibodies against p.gingivalis, suggesting an infection by p.gingivalis in the central nervous system. In addition, the company recently announced the initiation of a Phase I trial with its new drug candidate COR588. 64 healthy participants will receive either placebo or COR588. COR588 is a second-generation small-molecule lysine-gingipain inhibitor differentiated from COR388 by its improved pharmacokinetic properties and anticipated once daily oral administration.