GAIN Trial Reaches Milestone With 500 Patients Enrolled

GAIN Trial Reaches Milestone With 500 Patients Enrolled
Cortexyme has reached a milestone after enrolling 500 patients with mild to moderate Alzheimer's disease in its ongoing Phase 2/3 GAIN clinical trial testing the company's investigational treatment COR388 (atuzaginstat). Enrollment for GAIN (NCT03823404) has been open since the second quarter of 2019, with recruitment ongoing at sites in the U.S. and Europe. Data from an interim analysis — scheduled to occur after 300 patients reach 24 weeks of treatment with COR388 — is expected by the end of 2020. A full analysis of the trial data, which will occur after all patients have reached one year of treatment, is expected by the end of 2021. “We are gratified to see the continued high level of engagement of our clinical sites and study participants and their caregivers, especially during the last several months,” said Michael Detke, MD, PhD, chief medical officer of Cortexyme, in a press release. Reaching the enrollment milestone, especially given the COVID-19 pandemic and its limitations, underscores both the need for an Alzheimer's treatment and the potential therapeutic benefit of COR388, according to Cortexyme. COR388 is designed to inhibit toxic protease enzymes, also called gingipains, produced by the bacteria P. gingivalis. Gingipain proteins have been found in more than 90% of post-mortem brain samples from Alzheimer's patients. Furthermore, studies using animal models have shown that the presence of gingipains can trigger Alzheimer's pathology, prompting researchers to investigate COR388 as a treatment for the disease. The GAIN trial seeks to recruit 573 patients from the ages of 55 to 80 with a confirmed diagnosis of mild to moderate Alzheimer's, at several testing centers across the U.S. and Europe. The trial is testing the efficacy
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