Resverlogix Expands Phase 2b Clinical Trial for COVID-19 Treatment with First Site in Brazil and Second in Canada
CALGARY, Alberta, Feb. 17, 2022 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix") (TSX:RVX) today announced that the first Brazilian site has been initiated for its Phase 2b study to evaluate the safety and efficacy of Canadian-developed apabetalone as a potential oral treatment for COVID-19. Additionally, the second Canadian site, in Calgary, Alberta, has also been initiated. A further five sites in Brazil and a third Canadian site, in Toronto, Ontario, will also be coming on line soon.
“We are excited to be collaborating with Brazil on our Phase 2b clinical study, as part of our active and ongoing work with hospitals and ministries globally, to enroll and dose patients in our COVID-19 clinical trials,” said Donald J. McCaffrey, President & CEO of Resverlogix. “In consultation with Health Canada, we’ve updated our study protocol to account for the new variants, which could positively enhance the swiftness of patient enrollment. Our goal is to continue advancing the clinical development of apabetalone, thus providing critical and affordable help in the fight against the ongoing pandemic.”
Apabetalone’s unique dual epigenetic mechanism may help stop disease progression by regulating the expression of disease and inflammation causing genes, without altering DNA. Through this mechanism, apabetalone has the potential to address both the viral and the more deadly inflammatory aspects of COVID-19.
In the randomized, open-label trial, study participants will either receive twice daily oral doses of apabetalone or, alternatively, standard of care alone. A total of 100 patients are expected to be enrolled over the coming weeks, at multiple sites in Brazil and Canada. The primary outcome measure of the study will be a change in the WHO Ordinal Scale for Clinical Improvement – a standardized method of assessing COVID-19 disease severity on an 8-point scale. Secondary endpoints will include evaluating the effect of apabetalone on biomarkers of inflammation.
A summary of the study protocol can be viewed HERE.
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 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.
A Phase 2b clinical trial is evaluating apabetalone in combination with standard of care for patients hospitalized with COVID-19. 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, 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 Phase 2b clinical trial 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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