Resverlogix Announces Publication of Key Apabetalone Study BETonMACE in the Journal of the American Medical Association - Seite 2

JAMA Publication Highlights include:

• Apabetalone recently completed the first ever Phase 3 clinical trial of a BET inhibitor for a cardiovascular disease indication
• Although not reaching significance in its primary outcome measure, apabetalone treatment provided a promising trend towards reduction in MACE (10.3% in apabetalone-treated and 12.4% in placebo-treated patients, hazard ratio 0.82, 95% CI 0.65-1.04), among type 2 diabetic patients with acute coronary syndrome (ACS) and low HDL cholesterol
• Clinically significant reduction in the risk of hospitalization due to CHF was observed
• Clinically significant reductions in the primary endpoint were observed in pre-specified subgroups of the trial population, including those with a baseline estimated glomerular flow rate (eGFR) of less than 60 mL/min/1.73 m²
• Apabetalone continued its long proven safety record in this trial, with the treatment group reporting similar rates of adverse events to the placebo group

Publication Background and Conclusions:

Apabetalone is an inhibitor of BET proteins, which has been shown in a number of applications to target markers and pathways associated with cardiovascular disease progression. In previous clinical trials, apabetalone reduced the incidence of major adverse cardiac events (MACE) by up to 62% in various cardiovascular disease patient populations. Although treatment did not produce a statistically significant hazard reduction in the primary outcome measure, there was a strong trending hazard reduction – comparable with that of other cardiovascular outcome trials that led to approvals – and the authors of the publication and editorial suggest a larger trial with expanded endpoints may yield a different result.

About Resverlogix

Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. Apabetalone is the first therapy of its kind to have been granted US FDA Breakthrough Therapy Designation – for a major cardiovascular indication – to help facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy.

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.