CALGARY, Alberta, Sept. 28, 2022 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the “Company”) (TSX:RVX) today announced that apabetalone’s future clinical development related to COVID-19 will focus on the prevention and treatment of Post COVID-19 Conditions (PCC), colloquially known as long-COVID, as opposed to hospitalized COVID-19 patients, reflecting the compelling opportunity for apabetalone to benefit PCC patients and guidance from the US Food and Drug Administration (FDA).
A recent estimate from the US Centers for Disease Control and Prevention (CDC) suggests that as many as one-in-three US adults may experience long-COVID after contracting COVID-19. Vaccination against COVID-19 helps reduce the risk of PCC, but only by as little as 15%, according to a recent study of more than 13 million people.
“Patients around the world are dealing with persistent COVID-19 symptoms, often lasting weeks and months after their initial infections,” said Dr. Michael Sweeney, Senior Vice President, Clinical Development at Resverlogix. “There are currently few available treatment options for this group of people, and we feel that apabetalone has great potential to help them. We know that individuals who contract COVID-19 are at greater risk of negative cardiovascular outcomes, and we have seen the cardioprotective benefit of apabetalone in other high-risk populations.”
Regarding the recent FDA meeting, Dr. Sweeney added: “We are grateful to the FDA for the feedback and suggestions provided in our recent Type C meeting, and we look forward to continuing to work with regulators in our evaluation of apabetalone’s safety and efficacy in treating Post COVID-19 Conditions.”
The Company is finalizing the Phase 3 study protocol of apabetalone in PCC and plans to launch the trial in the first half of 2023, subject to all necessary regulatory and other applicable approvals and securing the necessary resources.
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 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.
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 post COVID-19 conditions. 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 global commercialization of apabetalone for COVID-19. EVERSANA™ is currently leading clinical outreach and advocacy for apabetalone.
Apabetalone is 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, 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. 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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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 planned COVID-19 trial and the potential role of apabetalone in the treatment of patients with COVID-19, 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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