Dr. Peter Toth reports
RESVERLOGIX PUBLISHES NEW DATA HIGHLIGHTING APABETALONE'S BENEFIT IN NON-ALCOHOLIC FATTY LIVER DISEASE
Resverlogix Corp. has published an article entitled "Reduction in the Risk of Major Adverse Cardiovascular Events with the BET Protein Inhibitor Apabetalone in Patients with Recent Acute Coronary Syndrome, Type 2 Diabetes, and Moderate to High Likelihood of Non-Alcoholic Fatty Liver Disease" in the American Journal of Preventive Cardiology. The article presents a posthoc analysis of BETonMACE data, which demonstrate apabetalone treatment improves cardiac outcomes and liver fibrosis scores in patients with moderate-to-high likelihood of advanced liver fibrosis.
"In this patient group, apabetalone treatment was associated not only with fewer negative cardiovascular outcomes, but also relative improvements in liver fibrosis score," said Dr. Peter P. Toth, director of preventive cardiology at CGH Medical Center in Sterling, Ill., and the corresponding author of the article. "These promising findings make the case for a larger study of non-alcoholic fatty liver disease patients to better understand the scope of apabetalone's benefit."
Publication highlights include:
Angulo fibrosis score (FS) has a validated association with non-alcoholic fatty liver disease prevalence.
BETonMACE participants with an elevated FS had higher incidences of major adverse cardiac events (MACE) and hospitalizations due to heart failure (HHF).
Apabetalone treatment reduced the hazard of HHF, as well as a composite MACE and HHF in BETonMACE participants with elevated FS.
In comparison with the placebo group, patients who received apabetalone treatment saw significantly smaller increases in their liver fibrosis scores.
Apabetalone (RVX-208) is a first-in-class, small-molecule, therapeutic candidate with an epigenetic mechanism of action. It is a BD2 (bromodomain) selective BET (bromodomain and extraterminal) inhibitor that works in preventing and treating disease progression by regulating the expression of disease-causing genes.
Due to the extensive role for BET proteins in the human body, apabetalone can simultaneously target multiple disease-related biological processes while maintaining a well-described safety profile -- leading to a new way to treat chronic disease. Apabetalone received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) and is the only drug of its class with an established safety record in human clinical trials, with well over 4,200 patient-years of safety data across 10 clinical trials.
Studies published in prestigious scientific journals (including Cell) demonstrate that apabetalone has the potential to act against COVID-19 with a unique dual-mechanism: first by preventing viruses from entering the cells and replicating; and second by averting excessive inflammatory reactions that can cause severe and lasting organ damage. The investigational treatment could potentially reduce the severity and duration of COVID-19. Apabetalone's unique dual-mechanism also means that it has the potential to show efficacy against new COVID-19 variants and may even help fight other viruses.
Resverlogix has partnered with Eversana, the pioneer of next-generation commercial services to the global life sciences industry, to support the rapid commercialization of apabetalone for COVID-19 in Canada and the United States. Eversana is currently leading clinical outreach and advocacy for apabetalone in the Canadian market.
Apabetalone is the first therapy of its kind to receive breakthrough therapy designation from the U.S. Food and Drug Administration for a major cardiovascular indication following the groundbreaking findings from the BETonMACE phase 3 study. Data from BETonMACE showed apabetalone can potentially prevent major adverse cardiac events among high-risk cardiovascular disease patients who also have Type 2 diabetes mellitus.
Founded in 2001, Resverlogix is a Calgary-based late-stage biotechnology company and the world leader in epigenetics with the goal of developing first-in-class therapies for the benefit of patients with chronic disease.
Resverlogix is developing a new class of epigenetic therapies designed to regulate the expression of disease-causing genes. It aims to improve patients' lives by restoring biological functions altered by serious illnesses, such as cardiovascular disease, back to a healthier state.
The company's clinical program is focused on evaluating the lead epigenetic candidate apabetalone for the treatment of cardiovascular disease and associated comorbidities, and COVID-19.
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