On 26 September, Cortexyme, a clinical-stage pharmaceutical company developing novel treatments for altering the course of Alzheimer’s disease (AD) and other neurodegenerative disorders, announced that its GAIN Phase II/III trial has commenced recruitment in Europe. The study, which started enrolment in Q2 2019 in the US, is evaluating COR388 for the potential treatment of mild to moderate AD.
Previous findings suggested that the bacteriaP. gingivalis, commonly associated with gum disease, can infect the brain and may contribute to the development of AD. COR388 is an investigational drug designed to reduce the bacterial infection and stop or slow the disease progression by deactivating the toxic proteins released by theP. gingivalisbacteria, called gingipains. In Phase I testing, COR388 was well-tolerated and showed positive trends in cognitive tests.
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 AD. The company is aiming to recruit 573 participants in the US and Europe who will receive COR388 or placebo for 48 weeks. The primary endpoint is the mean change in the activities of daily living at week 48, measured by the Alzheimer Disease Cooperative Studies- activities of daily living (ADCS-ADL) scale. Data are expected in late 2021.