On 12 November, Cortexyme, a clinical-stage pharmaceutical company developing novel treatments for altering the course of Alzheimer’s disease (AD) and other neurodegenerative disorders, announced financial results and provided an update on its GAIN clinical trial. 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 recruited 643 research participants in the US and Europe, and exceeded its target enrolment by approximately 12%. An interim analysis, which is being conducted by an independent Data Monitoring Committee, is scheduled for December 2020.
On 5 November, Cortexyme presented the design of its GAIN trial and its baseline data at the 13th Clinical Trials on Alzheimer’s Disease (CTAD) meeting. Findings showed that participants enrolled in the trial have baseline biomarkers consistent with AD and potential responders to COR388. “We are pleased with the strong participation in the GAIN Trial and deeply appreciate the support and dedication of patients and the medical community as we approach the interim analysis before the end of this year,” said Casey Lynch, Cortexyme’s chief executive officer, co-founder, and chair.