On 4 November, Cortexyme, a clinical-stage pharmaceutical company developing novel treatments for altering the course of Alzheimer’s disease (AD) and other neurodegenerative disorders, announced that the independent Data Monitoring Committee (DMC) conducted a pre-planned interim analysis on the Phase II/II GAIN trial of COR388. 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 interim analysis included approximately 300 research participants who have reached six months of treatment. As part of the interim analysis, the DMC looked for futility and efficacy and recommended Cortexyme to continue the GAIN Trial as planned to the one-year endpoint. The company recruited 643 research participants in the US and Europe and top line results for the fully enrolled population are expected in December 2021.
