Apabetalone treatment was associated with a 52% hazard reduction for MACE events such as CVD death and Heart Failure, compared to placebo
CALGARY, Alberta, April 27, 2021 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today the recent publication of an article titled: “Effect of Apabetalone on Major Adverse Cardiovascular Events in Patients with Chronic Kidney Disease, Type-2 Diabetes Mellitus and Recent Acute Coronary Syndrome: Results from the BETonMACE Randomized Controlled Trial”, in the high-impact, peer-reviewed Clinical Journal of the American Society of Nephrology. The article was accompanied by a peer-reviewed editorial, published in the same journal, titled: “Novel Therapeutic Options for Cardiovascular Disease with CKD”.
“To my knowledge this is the first time that a cardiovascular risk reducing intervention – apabetalone – has shown such an improvement in clinical outcomes in patients with chronic kidney disease (CKD) – defined as an estimated glomerular filtration rate of less than 60 mL/min/1.7m2 – in a randomized placebo-controlled double-blind trial; and this is also the first time that an epigenetic modulator in the form of an oral pill has been studied in CKD,” stated Dr. Kam Kalantar-Zadeh of the University of California Irvine, member of the BETonMACE Clinical Steering Committee, and lead author of the paper. “In a prespecified analysis of the BETonMACE study, patients with CKD experienced significantly fewer major adverse cardiovascular events when treated with apabetalone compared to placebo. These data warrant further clinical research and development of apabetalone in patients with high-risk CKD.”
In an editorial published alongside the new research, Dr. Carmine Zoccali, and Dr. Francesca Mallamaci, Nephrology Division, Grande Ospedale Metropolitano, Reggio Calabria, Italy, contextualized these new findings, emphasizing the unmet clinical need for patients suffering from diabetes and CKD, and highlighting the potential of apabetalone to benefit this group.
“All in all, apabetalone seems to be endowed with a peculiar cardiovascular protection in patients for CKD,” wrote Dr. Zoccali and Dr. Mallamaci in the editorial.
“The pronounced reduction in MACE seen in BETonMACE CKD patients highlights the potential benefit these patients could receive from apabetalone treatment,” said Donald McCaffrey, President and CEO of Resverlogix. “Patients with CKD, type-2 diabetes and established cardiovascular disease will be the primary target patient population for our upcoming registration-enabling study, BETonMACE2.”
Publication Highlights include:
- In a pre-specified analysis in patients with CKD, participants in the placebo group with CKD experienced double the incidence of MACE (defined as cardiovascular death, nonfatal myocardial infarction, stroke, and hospitalization for congestive heart failure) than those without CKD
- Apabetalone treatment was associated with a 52% hazard reduction for MACE events such as CVD death and Heart Failure, compared to placebo (p=0.03); early and progressive separation in events occurred between the two groups
- A statistically significant reduction in alkaline phosphatase, a reported risk marker for CKD, was observed in patients with CKD after 24 weeks of apabetalone treatment (p=0.004)
- In addition, fewer serious adverse events were also observed in the apabetalone treated group compared to placebo (p=0.02)
Publication Background and Conclusions:
Chronic Kidney Disease is associated with a high burden of cardiovascular disease and poor clinical outcomes despite current standard of care treatment options. This prespecified analysis illustrated that treatment with apabetalone, in patients with stage 3 or worse CKD, diabetes and a recent acute coronary syndrome, was associated with a lower incidence of MACE. This finding demonstrates that apabetalone may offer a safe and effective treatment option for this high-risk group of 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.