Dr. Michael Sweeney reports
RESVERLOGIX CONFIRMS FOCUS ON TREATMENT OF POST COVID-19 CONDITIONS
Resverlogix Corp. has stated 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 U.S. Food and Drug Administration (FDA).
A recent estimate from the U.S. Centers for Disease Control and Prevention (CDC) suggests that as many as one in three U.S. 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 per cent, 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 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 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 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 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 co-morbidities and COVID-19.
Resverlogix's common shares trade on the Toronto Stock Exchange.
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