Cortexyme Announces GAIN Trial of Atuzaginstat in Alzheimer’s Disease Has Exceeded Study Enrollment Target of 570 Patients
- Interim analysis of the Phase 2/3 GAIN Trial expected to occur before year-end 2020
The GAIN Trial was designed to enroll patients with mild to moderate Alzheimer’s disease, randomized 1:1:1 to receive atuzaginstat 40 mg twice a day, 80 mg twice a day a day, or placebo. GAIN Trial enrollment has already exceeded the enrollment targets in the three double-blind arms. Although new screening of patients for the double-blind arms has ended, eligible patients who have already screened for the study will continue to enroll over the next several weeks.
“The GAIN Trial is an important study of a potential new approach to addressing Alzheimer’s. We are pleased the trial has reached this milestone on schedule, and we look forward to completing the trial’s interim analysis before year-end 2020,” said
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.
For more information about the GAIN Trial, visit www.GAINtrial.com.
About the GAIN Trial
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 the fourth quarter of 2021. For more information on the trial, visit www.gaintrial.com.
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the timing and success of our clinical trials and related data including the outcome of the interim analysis, the potential of atuzaginstat to treat Alzheimer’s disease, our ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. Forward-looking statements are based on Cortexyme’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K filed with the
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