The GAIN Trial’s protocol includes an interim analysis on the study’s co-primary cognitive and functional endpoints after approximately 300 patients reach 24 weeks of treatment; this interim analysis is expected to occur before year-end 2020. Top-line results of the GAIN Trial’s final analysis, to be performed once all study subjects complete the one-year study, are expected in 4Q-2021.
The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer’s Disease) Trial is a randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating the efficacy, safety, and tolerability of atuzaginstat (COR388), Cortexyme’s investigational gingipain inhibitor, in patients with mild to moderate Alzheimer’s disease. The GAIN Trial also includes a sub-study measuring the efficacy of COR388 on symptoms of periodontal disease including gingival pocket depth. The GAIN Trial has been enrolling since the second quarter of 2019, with top-line results from the study’s final analysis expected in 4Q-2021.
Atuzaginstat targets the toxic proteases, or gingipains, produced by P. gingivalis, which have been discovered in greater than 90% of post-mortem brains of patients with AD and shown to produce Alzheimer’s pathology in infected animals. P. gingivalis is best known as a keystone bacterium in the development of periodontal disease. The GAIN Trial includes a periodontal sub-study, in which approximately 40% of GAIN Trial participants are also assessed for endpoints of efficacy in periodontal disease. Of the sub-study participants enrolled to date, greater than 90% had moderate to severe periodontal disease at baseline.