Resverlogix Receives US FDA Breakthrough Therapy Designation for Apabetalone


Resverlogix Corp. (TSX: RVX) has announced the U.S. Food & Drug Administration has granted Breakthrough Therapy Designation for apabetalone in combination with top standard of care, including high-intensity statins, for the secondary prevention of major adverse cardiac events in patients with type 2 diabetes mellitus and recent acute coronary syndrome.

Donald McCaffrey

“This extremely exciting development significantly supports our commercialization plans for apabetalone,” said Donald McCaffrey, President and CEO. “The FDA recognizes that apabetalone, in combination with top standard of care therapies, is a novel way to address a major unmet need. This important designation – the first for a major cardiovascular indication – entails working closely with the FDA to facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy for apabetalone. We look forward to working with the FDA on next steps and updating our stakeholders on future material developments.”


In the fall of 2019, Resverlogix reported results from the groundbreaking Phase 3 trial BETonMACE. Apabetalone treatment significantly reduced hospitalizations due to congestive heart failure in comparison to placebo with top standard of care, as well as improving cardiovascular outcomes in two pre-specified subpopulations including those with chronic kidney disease. Significant improvements in cognition, as measured by Montreal Cognitive Assessment (MoCA) and relative to placebo with top standard of care, were also observed in cardiovascular disease patients with moderate to severe cognitive decline. Apabetalone’s consistent safety profile was further validated by an analysis of adverse events in BETonMACE, and nine positive reports by the trial’s independent Data and Safety Monitoring Board.

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 inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. 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, diabetes mellitus, 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.

Cardiology Magazine