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.
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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This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. In particular, this news release includes forward looking information related to the Company’s registration-enabling study – BETonMACE2 – and the potential role of apabetalone in the treatment of 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. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR at www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.