Successful CANTOS Inflammation Trial Supports Rationale for Resverlogix' Ongoing BETonMACE Trial

CALGARY , Aug. 29, 2017 /CNW/ - Resverlogix Corp. ("Resverlogix" or the "Company") (RVX.TO) is pleased to announce that key findings from the recently completed CANTOS trial, which demonstrate that targeting residual inflammatory risk resulted in a reduction in the incidence of Major Adverse Cardiovascular Events ("MACE"), validate the importance of reducing inflammation as a therapeutic strategy for treating Cardiovascular Disease ("CVD").

Novartis' Phase 3 CANTOS trial was designed to investigate the efficacy, safety and tolerability of ACZ885 (canakinumab) in combination with standard of care in people with a prior heart attack and heightened inflammation.  Similar to Resverlogix' ongoing Phase 3 BETonMACE trial, the primary endpoint of the CANTOS study was time to first occurrence of a narrowly defined 3-point MACE, a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.

As reported on the CardioBrief website, the CANTOS trial is "being hailed by experts for finally validating the role of inflammation in heart disease." CANTOS demonstrated the benefit of targeted therapy, an evolving paradigm in medicine. Similarly, treatment with Resverlogix' apabetalone has demonstrated a reduction in the inflammatory mediator IL-6 by 29 percent and positively modified the neutrophil/lymphocyte ratio, a well-known marker of inflammation in cardiovascular patients, analogous to the recent observations from CANTOS. This information is included in the Resverlogix posters being presented at the European Society of Cardioligists ("ESC") Congress 2017, as noted below, and available on the Company website HERE. This data potentially explains the MACE reduction results observed in Resverlogix's Phase 2 trials.

Mr. Donald McCaffrey , President and CEO, stated, "The CANTOS trial is a major advancement in proving that inflammation and not just lipids underlie cardiovascular disease. This trial validates, for the first time, that anti-inflammatory therapies can address the residual risk in cardiovascular disease that exists despite intense lipid management. Our lead drug, apabetalone, has marked effects on reducing key inflammation markers such as CRP, IL6 and MCP1, and other biological pathways important for innate immunity, coagulation and calcification. In fact, Resverlogix's previous Phase 2 broad MACE results in trials with apabetalone compare favourably to the reported CANTOS results. For this reason, we remain optimistic about and look forward to completion of BETonMACE. Our Phase 3 trial will test for the first time, that by modulating the multiple pathways underlying CVD, including inflammation, by epigenetic modification, we can reduce MACE outcomes in high risk patients."

Professor Kausik Ray , Imperial College London, and Chairman of the BETonMACE Clinical Steering Committee, commented, "the BETonMACE Phase 3 trial is designed to test for a reduction in MACE in high risk CVD patients with diabetes who have residual inflammatory risk (and much higher absolute risk than patients in the CANTOS trial). Patients included in BETonMACE are those with a recent heart attack and diabetes, both of which result in a highly inflamed vasculature and the CANTOS results are encouraging for the potential success of the BETonMACE trial. Further, the BETonMACE population represent a huge unmet medical need with a predicted annual CVD event rate of over 7 percent which compares to about 4.3 percent in the CANTOS study."

Resverlogix Hosted Satellite Symposium at the ESC Congress 2017

The Company also announced today that on Saturday, August 26, 2017 , it hosted a symposium titled: "Managing Diabetes & CVD: Is epigenetics a new way forward?" at the ESC Congress 2017.

The agenda and speakers were as follows:

Introduction
Lina Badimon, MD – Barcelona, Spain

Managing high risk diabetes patients with cardiovascular disease: What works, and what else can we do? - Kausik Ray , MD - Imperial College London, United Kingdom

Promise of epigenetic modulation as a target in atherosclerotic patients 
- Erik Stroes , MD - Academic Medical Centre, Amsterdam, Netherlands

Insights from the first trials in epigenetics in human: What is the way forward? 
- Stephen Nicholls , MD - Adelaide, Australia