Cortexyme Provides Regulatory Update on Development Program for Atuzaginstat in Alzheimer’s Disease
- Double-blind phase of GAIN Trial to continue as planned, with top-line data expected Q4 2021
- Open-Label Extension of atuzaginstat to stop dosing and enrollment
The partial clinical hold was initiated following the review of hepatic adverse events in the atuzaginstat trial by the FDA. These events have been reversible and without any known long-term adverse effects for the participants.
“Cortexyme’s highest priority is the safety of study participants,” said
About the GAIN Trial and its Open Label Extension
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 includes a sub-study measuring the efficacy of atuzaginstat on symptoms of periodontal disease including gingival pocket depth. Top-line results from the GAIN Trial’s final analysis are expected in the fourth quarter of 2021. For more information on the trial, visit www.gaintrial.com.
The GAIN Trial protocol also includes an open-label extension (OLE) study in
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 the partial clinical hold and ongoing correspondence with the FDA, and its related impact on the timing and success of our clinical trials, including with respect to atuzaginstat, the double-blind, placebo-controlled randomized phase of the GAIN Trial and open-label extension phase; the timing of announcements and updates relating to our clinical trials and related data; the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds; statements about our ability to obtain, and the timing relating to, and regulatory submissions and approvals with respect to our drug product candidate. 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
Chief Operating Officer