Resverlogix Corp and the Resverlogix BETonMACE Clinical Steering Committee (CSC), represented by Professor Kausik Ray (Chair), are pleased to announce the FDA acceptance of the company s phase 3 BETonMACE trial Protocol amendments.

On behalf of all members of the BETonMACE CSC, Professor Kausik Ray welcomed the addition of US-based sites to the ongoing cardiovascular disease (CVD) outcomes trial, BETonMACE. The BETonMACE trial will now be expanded beyond Europe, Asia and South America to a fourth continent North America with the addition of the United States. Prof. Ray commented, The addition of the United States is timely as we plan to conduct a Sample Size Recalculation Analysis ('SSRA') later in the first half of 2018. BETonMACE is currently targeted to include 2,400 participants to yield 250 MACE events and this number may be increased if required. Enrolling patients from the major regions of the world will provide evidence of generalizability in different healthcare systems and in different populations should apabetalone show improvement in cardiovascular outcomes. The FDA acceptance of the BETonMACE trial in US centers is an important milestone in the development of this compound.

Further, Donald McCaffrey, president and chief executive officer, stated, "I am extremely pleased with the continued progress of the BETonMACE trial. We have already enrolled over 2,200 patients and expanding territories and potentially number of patients beyond 2,400 may be beneficial in several ways, scientifically and commercially. BETonMACE top line data is still planned to be available around the end of 2018.

The CSC is responsible for oversight and strategic direction for the Company s phase 3 BETonMACE trial. The BETonMACE study, Effect of RVX-208 on Time to Major Adverse Cardiovascular Events (MACE) in High-Risk Type 2 Diabetes Mellitus Subjects with Coronary Artery Disease, commenced in October 2015. The study is a large international multicenter, double-blind, randomized, parallel group, placebo-controlled clinical trial to determine whether treatment with apabetalone in combination with rosuvastatin or atorvastatin increases the time to MACE compared to treatment with rosuvastatin or atorvastatin alone. The primary endpoint of the BETonMACE trial is designed to show a relative risk reduction of MACE, narrowly defined as a single composite endpoint of cardiovascular death, non-fatal myocardial infarction ( MI ) and stroke. The study is an event-based trial and will continue until at least 250 MACE events have occurred.