Mr. Donald McCaffrey reports
APABETALONE'S POSITIVE IMPACT ON PULMONARY ARTERIAL HYPERTENSION PUBLISHED IN THE AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
Resverlogix Corp. has published an article entitled "BET Protein Inhibition for Pulmonary Arterial Hypertension: A Pilot Clinical Study," in the prestigious American Journal of Respiratory and Critical Care Medicine -- which has an impact factor of 21.4. The article outlines the positive impact of apabetalone in the investigator-led pulmonary arterial hypertension (PAH) pilot study, APPRoAcH-p.
"The encouraging results published today highlight the potential benefit of BET protein inhibition, such as Resverlogix's apabetalone, as a therapeutic strategy for PAH," said Dr. Steeve Provencher, director of pulmonary research, Quebec Heart and Lung Institute, Laval University, and the lead author of the article. "We are excited to be moving forward with a larger trial of apabetalone in PAH patients."
Publication highlights include:
All patients completed the 16-week trial without discontinuation or dose reduction, suggesting that apabetalone was well tolerated in the study population.
- Patients treated with apabetalone exhibited a reduction in pulmonary vascular resistance (PVR) at 16 weeks, the key exploratory efficacy end point of the study.
- Apabetalone treatment was also associated with improved cardiac output (CO) and stroke volume (SV) over the 16-week treatment course.
"The APPRoAcH pilot study showed the potential benefit that apabetalone can offer for PAH patients," said Donald J. McCaffrey, president and chief executive officer of Resverlogix. "We are thrilled to be working with Dr. Provencher, and his colleagues at the Quebec Heart and Lung Institute, to help bring this life-saving treatment to market. We also want to recognize the important contribution of the IUCPQ Foundation to this work."
Full trial results will be presented at a coming scientific meeting (to be determined). The encouraging results of this study pave the way for the larger multicentred APPRoAcH-2 trial, which is expected to begin enrolling patients later this year, and will be a phase 2, randomized, placebo-controlled study of apabetalone for the treatment of PAH.
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 on drug across 10 clinical trials.
Following a publication in Nature, authored by a consortium of top universities and research institutions, on March 23, 2020, Resverlogix launched a COVID-19 program conducting research internally and enlisting world-renowned collaborators. 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.
A phase 2b clinical trial is evaluating apabetalone in combination with standard of care for patients hospitalized with COVID-19. 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.
In February, 2020, apabetalone became the first therapy of its kind to receive breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) 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, or gene regulation, 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. The company 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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