Apabetalone’s Positive Effect on Hospitalized Patients Involving Heart Failure

Cardiovascular Publication Explores the Prespecified BETonMACE Analysis on Hospitalization for Heart Failure Following Acute Coronary Syndrome

CALGARY, Alberta, Jan. 12, 2021 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today the recent publication of an article titled: “Apabetalone and hospitalization for heart failure in patients following an acute coronary syndrome: a prespecified analysis of the BETonMACE study”, in the high-impact, peer-reviewed Cardiovascular Diabetology.

The publication can be viewed using the following LINK.

“In this prespecified analysis from the BETonMACE study, significantly fewer hospitalizations for heart failure (HHF) in patients with type 2 diabetes and a recent history of acute coronary syndrome (ACS) were observed in the apabetalone treatment group compared to placebo,” said Dr. Stephen J. Nicholls of Monash University, member of the BETonMACE Clinical Steering Committee, and lead author of the paper.

“The unprecedented reduction in heart failure seen in BETonMACE further demonstrates the broad benefit these patients receive from apabetalone treatment,” said Donald McCaffrey, President and CEO of Resverlogix. “In agreement with the US Food and Drug Administration (FDA) – following receipt of the Company’s Breakthrough Therapy Designation announced on February 3, 2020, we will be including HHF in the composite primary endpoint for our upcoming registration-enabling study, BETonMACE2.”

Publication Highlights include:

• BETonMACE was the first, and only, Phase 3 clinical trial to evaluate the cardiovascular efficacy and safety of a BET protein inhibitor
• Apabetalone treatment, in a pre-specified analysis, was associated with a 41% hazard reduction for first hospitalization for heart failure compared to placebo (p=0.03) with qualitative evidence of an early and progressive separation in events between the two groups
• When total hospitalizations for heart failure were analyzed, apabetalone treatment demonstrated a significant 53% hazard reduction (p=0.01)
• The combination of either first hospital admission for heart failure or cardiovascular death occurred less frequently in apabetalone than placebo-treated patients (28% hazard reduction, p=0.04)
• Following 24 weeks of apabetalone treatment, a statistically significant increase in high-density lipoprotein (HDL) (15.4%; p<0.0001) and decrease in alkaline phosphatase (ALP) (-8.31%; p<0.0001) was observed compared to the placebo group
• These findings contribute to apabetalone’s beneficial effect on cardiovascular outcomes observed in BETonMACE

Publication Background and Conclusions:

Despite current standard of care treatment options, patients with diabetes and ACS have a high risk of experiencing subsequent cardiovascular events, including those related to congestive heart failure. This prespecified analysis, illustrated that treatment with apabetalone following an ACS was associated with a lower incidence of hospital admission for heart failure. This finding provides the rationale to further explore apabetalone’s effect on HHF and highlights a potential new therapeutic strategy to benefit these high-risk patients. Previously reported BETonMACE details can be found using the following LINK.  

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.

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

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Email: ir@resverlogix.com
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