VANCOUVER, British Columbia, Sept. 30, 2022 (GLOBE NEWSWIRE) -- Resverlogix Corp. (TSX:RVX) (OTCPink:RVXCF), a world leader in epigenetics, or gene regulation, announced that apabetalone’s future development related to COVID-19, will focus on the prevention and treatment of Post COVID-19 Conditions. The company’s new focus on patients with Post COVID-19 Conditions (PCC), colloquially known as long-COVID, as opposed to hospitalized COVID-19 patients, reflects the compelling opportunity for apabetalone to benefit long-COVID patients along with guidance from the US Food and Drug Administration.
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Following the recent FDA meeting, Dr. Michael Sweeney, Senior VP, Clinical Development for Resverlogix, stated: “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.”
A recent estimate from the 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 long-COVID, but only by as little as 15%, according to a recent study of more than 13 million people.
Dr. Michael Sweeney, added: “Patients around the world are dealing with persistent COVID-19 symptoms, often lasting weeks and months after their initial infections. 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.”
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.
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 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. 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. 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.
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.
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