CALGARY, Alberta, June 14, 2018 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today that it has received confirmation from the U.S. Food and Drug Administration (“FDA”) that BETonMACE, Resverlogix’s on-going Phase 3 study, if successful, is likely to support the filing and approval of a New Drug Application (“NDA”). The statistical analysis plan and endpoints proposed by the Company were reviewed and accepted by the Division of Cardiovascular and Renal Products (“DcaRP”) of the FDA. The exact indication to be sought by the Company, and to be reviewed by the FDA, would be driven by the study’s results.

The ongoing Phase 3 BETonMACE trial has enrolled its planned target of over 2,400 patients. The trial patients are high-risk cardiovascular disease (“CVD”) patients with type 2 Diabetes Mellitus (“DM”) and low levels of high-density lipoprotein (“HDL”) who have recently (within 7-90 days) experienced an acute coronary syndrome (myocardial infarction or unstable angina). These patients are at very high CVD risk despite standard of care treatment. The primary endpoint of the BETonMACE trial is designed to establish a relative risk reduction (“RRR”) of Major Adverse Cardiac Events (“MACE”), narrowly defined as a single composite endpoint of cardiovascular death, non-fatal myocardial infarction or stroke. BETonMACE is an event-driven trial, and with recruitment complete, continues to accumulate MACE towards the required number.

“We are excited to receive feedback from the FDA that confirms the path forward for filing of an NDA for apabetalone, the first selective BET inhibitor for the treatment of high-risk cardiovascular disease. The FDA’s feedback is similar to that received previously from European authorities. We are now focused on completing the BETonMACE study together with other activities required for NDA and Marketing Authorisation Application (“MAA”) filings,” stated Donald McCaffrey, President and CEO of Resverlogix.