Resverlogix Announces Type C Meeting with FDA for CORAL, a Phase 3 High-risk COVID-19 Outpatient Study
CALGARY, Alberta, May 09, 2022 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix”, or “the Company”) (TSX:RVX), in partnership with EVERSANA™, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company’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 healthcare 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, multicenter, 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 underway, 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, M.D., 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 to 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 extra-terminal) 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 US 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 4200 patient-years of safety data 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 US Food and Drug Administration (FDA) – for a major cardiovascular indication – following the ground-breaking 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. We aim 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.
Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).
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EVERSANA™ is the leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.
Forward Looking Statements:
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 Phase 2b clinical trial, the planned Phase 3 study and the potential treatment of COVID-19 patients with apabetalone (and potentially other viruses), cardiovascular disease and associated comorbidities and other chronic 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.
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1 Xie, Y., Xu, E., Bowe, B. & Al-Aly, Z. Long-term cardiovascular outcomes of COVID-19. Nat Med 28, 583-590, doi:10.1038/s41591-022-01689-3 (2022).