CALGARY, Alberta, Nov. 01, 2021 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX: RVX), a world leader in epigenetics or gene regulation, is pleased to announce today that it is in active discussions with the Kingdom of Morocco’s Ministry of Health for possible Phase 2 COVID-19 clinical studies within their hospitals using first-in-class drug – apabetalone.
“We are pleased to collaborate with the Kingdom of Morocco’s Ministry of Health under the leadership of Professor Bouchra Meddah, Director of Medicines and Pharmacy, for the possible launch of COVID-19 clinical studies with our novel epigenetic drug apabetalone. It is imperative to clear hospital beds of COVID-19 patients to allow urgent surgeries and other necessities to take place, which will contribute to reopening and strengthening the economy in the Kingdom of Morocco,” said Donald J. McCaffrey, President & CEO of Resverlogix.
“The Kingdom of Morocco’s Ministry of Health is pleased to be collaborating with Resverlogix on this important global initiative that has tragically impacted so many people worldwide. Our team was very impressed by the publications from Cell Journal, Nature report, along with Health Canada and FDA approvals for COVID-19 clinical trials. Our Ministry has also recognized the FDA’s granting to Resverlogix the coveted Breakthrough Therapy Designation for apabetalone in a cardiovascular indication,” said Professor Bouchra Meddah, Director of Medicines and Pharmacy – Ministry of Health in the Kingdom of Morocco.
Following Health Canada’s approval for Resverlogix’s COVID-19 clinical trials, it has been actively working with hospitals and ministries to commence COVID-19 trials globally. On October 12th, 2021, Resverlogix received ethics committee approval for COVID-19 clinical trials in Western Canadian sites. Additionally, a Phase 3 COVID-19 trial in the US is anticipated to commence in coming months based on final protocol approval.
Phase 2 Trial Overview– Canada/Brazil
Study participants will be made up of patients hospitalized with confirmed COVID-19 cases. Participants will either receive twice daily doses of apabetalone for up to 4 weeks alongside standard of care, compared to standard of care alone. The primary outcome measure of the study will be change in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement. A total of 100 patients are expected to be enrolled at multiple sites in Canada and Brazil. The full study protocol can be found on clinicaltrials.gov.
Apabetalone (RVX-208), is a first-in-class, epigenetic small molecule, or gene regulating, therapeutic candidate. It is a selective BET (bromodomain and extra-terminal) inhibitor, which works in preventing disease by turning genes on and/or off through regulation of gene expression. The prevalence of BET proteins in the human body allows apabetalone, through its unique mechanism of action, to simultaneously target multiple disease-causing biological processes while maintaining a well described safety profile – leading to a new way to treat chronic disease.
In February 2020, apabetalone became the first therapy of its kind to receive Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) – for a major cardiovascular indication – following the ground-breaking findings from the BETonMACE Phase Three 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.
On March 23, 2020, Resverlogix launched its COVID-19 program, enlisting world-renowned collaborators. Studies demonstrate that apabetalone has the potential to act against COVID-19 with a unique dual-mechanism: the first pillar of apabetalone’s dual-mechanism is preventing viruses from entering the cells and replicating; the second pillar is averting runaway inflammatory reactions that can cause severe and lasting organ damage. A Phase Two clinical trial is evaluating apabetalone in combination with standard of care for patients hospitalized with COVID-19. Apabetalone treatment could potentially reduce the severity and duration of COVID-19. Apabetalone’s unique dual-mechanism also means that it is likely to show efficacy against COVID-19 variants and may even help fight other related viruses.
Apabetalone is the only drug of its class with a well-established safety record in human clinical trials, with well over 4200 patient-years on drug across 10 clinical trials.
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 commercializing a new class of epigenetic therapies designed to regulate gene expression, turning disease-associated genes “on” or “off”. 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 discussions with the Kingdom of Morocco’s Ministry of Health, the Company’s clinical trials and the potential role of Apabetalone in the treatment of patients with COVID-19 (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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