Resverlogix Corp. (TSX:RVX) reported today that it has observed the targeted 250 events in its Phase III BETonMACE trial which began in November 2015. The drug under investigation, apabetalone, is being investigated in a trial with 2,425 participants and was fully enrolled in March 2018. The study has a primary endpoint of time to first occurrence of Major Adverse Cardiac Event (MACE)1. The study will also examine kidney function in chronic kidney disease (CKD) patients as well as cognitive function in patients over 70 years of age. Topline data from the trial are expected mid-year.
View Exhibit I – BETonMACE Pipeline
As a reminder, BETonMACE is a Phase III multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial comparing 100 mg of apabetalone with high-intensity statin therapy with placebo and high-intensity statin therapy. The trial has lasted three and one half years and utilizes a first in class small molecule selective bromodomain extra-terminal (BET) protein inhibitor. Apabetalone targets bromodomain 2 and has demonstrated a favorable side effect profile
The trial is targeting a statistically significant 30% relative risk reduction in MACE in high-risk type 2 diabetes mellitus subjects with coronary artery disease. The high risk group was selected in order to accentuate the magnitude of impact of apabetalone in the population. Data from chronic kidney disease patients and vascular cognitive dementia patients will be used to design future trials and potentially be used to construct and pursue a Phase IV trial if approval is granted in the primary indication.
View Exhibit II – BETonMACE Trial Design
Following the conclusion of the trial, adjudication of all MACE events will occur in an effort that is expected to take approximately two months post trial completion. Top line data will be announced upon the completion of adjudication and investors will know if the trial has achieved its primary endpoint. Secondary endpoints and their details will also be released.
In its Thursday morning release, the company outlined the next steps expected over the next two to four months following the achievement of the targeted event rate.
‣ Last study visits beginning immediately. Visits will start at locations in order of number of patients enrolled. As this takes place, additional events are expected to occur, which can add to the statistical strength of the result.
‣ Three or four weeks after the last study visit, safety tracking will ensue with the post-apabetalone follow up visit.
‣ Simultaneous with the above efforts, the third-party adjudication committee will continue to adjudicate. Current adjudicated events are over 225.
‣ Patients who have discontinued the study will be contacted for a follow up visit.
‣ Database lock will occur for each patient after last questions are answered.
‣ ~Two weeks after the database lock is complete, expect primary, secondary and exploratory endpoints to be released.
‣ Full data expected to be announced at relevant conferences
◦ American Heart Association (AHA) Conference (November 2019) for cardiovascular
◦ Clinical Trials on Alzheimer’s Disease (CTAD) Conference (December 2019) for cognition
◦ American Society of Nephrology (ASN) Conference (November 2019) for renal
‣ Anticipate a second half 2019 submission to the FDA for approval.
◦ Submissions to other regulatory agencies to follow
Resverlogix is in the final stages of its Phase III clinical trial and if successful with its objective will be able to address 12 million patients in the US, EU, Japan and Canada with high risk acute coronary syndrome, high risk chronic kidney disease and dementia and vascular cognitive dementia. Resverlogix has provided a detailed pathway over the remainder of 2019 regarding expected milestones. Achieving the target event goal is an important achievement and we eagerly await topline data to evaluate the potential benefit of apabetalone which we expect mid-year.
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1 MACE is defined as a single composite endpoint of: 1) Cardiovascular death, or 2) Non-fatal myocardial infarction, or 3) Stroke.