Mr. Kevin McDermott reports
RESVERLOGIX ANNOUNCES TYPE C MEETING WITH FDA FOR CORAL, A PHASE 3 HIGH-RISK COVID-19 OUTPATIENT STUDY
The U.S. Food and Drug Administration (FDA) has granted Resverlogix Corp.'s request for a type C meeting to review the clinical trial protocol for its phase 3 study of apabetalone in high-risk COVID-19 outpatients. The meeting is scheduled for early August.
In response to the transformation of the COVID-19 pandemic, advancement to the phase 3 trial will target outpatients with multiple risk factors for serious outcomes, focusing where apabetalone has the greatest potential to impact patient outcomes. Resverlogix will conclude its phase 2 trial in hospitalized COVID-19 patients early, thus focusing its resources on the advanced phase 3 program. By targeting outpatients with multiple risk factors for serious outcomes, Resverlogix aims to lessen the strain on health care systems -- keeping COVID-19 patients out of hospitals by reducing disease severity in the short and long term.
"We're pleased to support this important evolution of apabetalone and Resverlogix in its phase 3 Coral study," said Kevin McDermott, Resverlogix chief commercial officer, Eversana. "The Eversana Complete commercialization model is built to support customer needs by offering flexibility to quickly adapt development and launch strategies to meet market demands."
Coral study design
The phase 3 multicentre randomized clinical trial, entitled: A Double-Blind Placebo Controlled Study to Assess the Efficacy and Safety of Oral Apabetalone in Elderly Subjects with COVID-19 Infection and High Risk for Severe Illness and to Explore the Potential to Limit Long-Term Symptoms
(Coral), will evaluate the safety and efficacy of apabetalone in preventing serious health outcomes in high-risk COVID-19 patients. Study site selection is currently under way, with sites expected in the United States, Canada and the Middle East.
"We are just starting to understand the serious, long-term, cardiovascular consequences of the COVID-19 pandemic," said Dr. Barry S. Zingman, MD, clinical director, infectious diseases, at the Montefiore Medical Center -- Moses Division, professor of medicine at the Albert Einstein College of Medicine, and a member of Resverlogix's COVID-19 scientific advisory board. "Emerging therapies, such as apabetalone, have the potential to help address the critical unmet need in these patients."
High-risk COVID-19 patients
A recently published, large-scale analysis of electronic health records found that individuals who have contracted COVID-19 are at significantly greater long-term risk for a broad range of negative cardiovascular outcomes, including acute coronary disease, heart attack, stroke and heart failure, compared with those who had never had the disease1. The study found elevated risks persisted long after the initial infection, even in people who were not hospitalized for COVID-19, and were most pronounced among high-risk patients -- including those with a history of cardiovascular disease, those with pre-existing comorbidities and those over the age of 65.
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.
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, 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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