CALGARY, Alberta, April 27, 2021 (GLOBE NEWSWIRE) Resverlogix’s Apabetalone Demonstrates a Medical First in Patients with Chronic Kidney Disease
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”.
The publication can be viewed HERE, and the accompanying editorial HERE.
“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.
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