Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) is pleased to announce the receipt of a positive Type C written response from the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration (FDA). In light of updated information regarding apabetalone, including: human exposure, clinical dosing and established acceptable safety margins, the FDA is allowing the Company to include United States of America (USA) patients in Phase 3 studies, including the BETonMACE trial. Resverlogix has agreed to make adjustments to the existing BETonMACE study protocol and to update the Investigator's Brochure and the Informed Consent Documents. The primary objective of the BETonMACE study is to evaluate if treatment with apabetalone in addition to standard of care (SoC) as compared to placebo increases time to the first occurrence of a major adverse cardiac event (MACE) in high-risk cardiovascular disease patients with type 2 diabetes mellitus.

Mr. Donald McCaffrey, President and CEO stated, "This is a major advancement for Resverlogix, having Phase 3 trial approval from both the European Authorities and FDA for apabetalone, which adds significant value to our program. FDA approval to proceed with the Phase 3 BETonMACE trial in the USA is well timed and should not have a major impact on the total duration of the BETonMACE trial." Mr. McCaffrey further commented, "This progress is very encouraging and further validates our recently released data that confirmed apabetalone's ability to differentially affect genes and proteins between advanced chronic kidney disease (CKD) patients and normal subjects."

Dr. Mike Sweeney, Senior Vice President of Clinical Development stated, "We are pleased to now have the opportunity to include USA patients in the global Phase 3 BETonMACE clinical trial with approval from the FDA. The BETonMACE trial, which commenced in 2015 via the European Authorities has been progressing on target with over 70% enrollment with multiple positive recommendations from the data safety monitoring board to continue the trial as planned. We welcome the opportunity to advance apabetalone in the USA."

About BETonMACE

In 2015, Resverlogix initiated a global Phase 3 clinical trial called BETonMACE with apabetalone for the reduction of major adverse cardiac events (MACE) in high-risk cardiovascular disease patients with type 2 diabetes mellitus and low high-density lipoprotein (HDL). The primary endpoint is to evaluate if treatment with apabetalone as compared to placebo increases time to the first occurrence of a major adverse cardiac event (MACE). MACE is defined as a single composite endpoint of:  cardiovascular death, non-fatal myocardial infarction, or stroke. Secondary endpoints include: revascularization and unstable angina; changes in apolipoprotein A-I (apoA-I), apolipoprotein B (apoB), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG); changes in Hemoglobin A1c (HbA1c), fasting glucose, and fasting insulin; and changes in alkaline phosphatase (ALP) and estimated glomerular filtration rate (eGFR) in Stage 3 CKD patients.

About Resverlogix

Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. BET bromodomain inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is the first and only BET inhibitor selective for the second bromodomain (BD2) within the BET protein called BRD4. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with high-risk cardiovascular disease (CVD), diabetes mellitus (DM), chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases, while maintaining a well described safety profile. Apabetalone is the only selective BET bromodomain inhibitor in human clinical trials. Apabetalone is currently being studied in a Phase 3 trial, BETonMACE, in high-risk CVD patients with type 2 DM and low high-density lipoprotein (HDL), and is expected to be initiated in a Phase 2a kidney dialysis trial designed to evaluate biomarker changes and safety parameters in up to 30 patients with end-stage renal disease treated with hemodialysis.

Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).