Apabetalone’s Positive Impact on Pulmonary Arterial Hypertension Published in the American Journal of Respiratory and Critical Care Medicine

Calgary, Alberta, CANADA


CALGARY, Alberta, March 17, 2022 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix") (TSX:RVX) today announced the publication of an article entitled “BET Protein Inhibition for Pulmonary Arterial Hypertension: A Pilot Clinical Study” in the prestigious American Journal of Respiratory and Critical Care Medicine – which has an impact factor of 21.4. The article outlines the positive impact of apabetalone in the investigator-led pulmonary arterial hypertension (PAH) pilot study, APPRoAcH-p.

The article can be found HERE

“The encouraging results published today highlight the potential benefit of BET protein inhibition, such as Resverlogix’s apabetalone, as a therapeutic strategy for PAH,” said Dr. Steeve Provencher, Director of Pulmonary Research, Quebec Heart and Lung Institute, Laval University, and the lead author of the article. “We are excited to be moving forward with a larger trial of apabetalone in PAH patients.”

Publication Highlights Include:

  • All patients completed the 16-week trial without discontinuation or dose reduction, suggesting that apabetalone was well tolerated in the study population
  • Patients treated with apabetalone exhibited a reduction in pulmonary vascular resistance (PVR) at 16 weeks, the key exploratory efficacy endpoint of the study
  • Apabetalone treatment was also associated with improved cardiac output (CO) and stroke volume (SV) over the 16-week treatment course

“The APPRoAcH pilot study showed the potential benefit that apabetalone can offer for PAH patients,” said Donald J. McCaffrey, President & CEO of Resverlogix. “We are thrilled to be working with Dr. Provencher, and his colleagues at the Quebec Heart and Lung Institute, to help bring this life-saving treatment to market. We also want to recognize the important contribution of the IUCPQ Foundation to this work.”

A primer on outcome measures used in this trial can be found HERE.

A summary of the APPRoAcH-p trial design can be found HERE

Next Steps:

Full trial results will be presented at an upcoming scientific meeting (to be determined). The encouraging results of this study pave the way for the larger multi-centered APPRoAcH-2 trial, which is expected to begin enrolling patients later this year, and will be a phase 2, randomized, placebo-controlled study of apabetalone for the treatment of PAH.

About Apabetalone

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.

COVID-19:

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.

Cardiology:

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.

About Resverlogix

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).

Follow us: Twitter: @Resverlogix_RVX. LinkedIn: https://www.linkedin.com/company/resverlogix-corp-/

About the Quebec Heart and Lung Institute – IUCPQ.qc.ca

Every year, 13,757* people are hospitalized and 115,654 visits were made on an outpatient basis for 41,670 users. The service area is more than 2 million people, which represents approximately 30% of Quebec’s population. Affiliated with the Laval University, the institution counts on the cooperation and the dedication of over 3,750 employees, physicians, professionals, researchers, managers as well as volunteers for providing quality care and services to both hospitalized and outpatient clienteles. In particular, the Institute offers programs of specialized and ultraspecialized care and services to treat cardiovascular and respiratory diseases as well as those related to obesity. The Institute’s physicians as well as health professionals have extensive expertise and contribute advancing the science of medicine. It also has as its mission to assess technologies and intervention methods in health. The Institute’s Research Centre is recognized internationally for the quality of its science.

* 2020–2021 financial data

About the IUCPQ Foundation

The IUCPQ Foundation’s role is to promote and support the IUCPQ-UL’s work, whose primary mission is the health of individuals with cardiovascular, respiratory, and obesity-related diseases. The annual research competition of the IUCPQ Foundation allows many researchers to undertake and continue work for the benefit of the population and the people with cardiovascular, respiratory, and obesity-related diseases. 

In recent years, the foundation contributed nearly $40 million by funding the purchase of specialized equipment as well as helping to fund research and education, and this, to the greater benefit of the population in central and eastern Quebec, which represents more than 2.2 million people.

About the Research Centre

The Research Centre’s vision is to play an international significant role in the fight against societal chronic diseases through its model of integrated science in cardiology, in respirology as well as in obesity–type 2 diabetes–metabolism. It counts on the cooperation of 177 researchers and physicians scientists, many of whom are recognized as being leaders in their field. These world-class researchers are among the most productive in Quebec. In addition, the perfect correspondence of the research components to the Institute’s specializations ensures a synergy between clinicians and researchers, thereby allowing a rapid knowledge transfer to the care.

For information about IUCPQ:

Joël Clément, M.A. Communications
Assistant, Human Resources and Communications
Responsible for external communications and media relations
Quebec Heart and Lung Institute – Laval University
418-656-4932
joel.clement@ssss.gouv.qc.ca

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 APPRoAcH-2 trial, its Phase 2b COVID-19 clinical trial and the potential treatment of PAH and COVID-19 patients with apabetalone (and potentially other viruses), as well as 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.

For further information please contact:

Investor Relations
Email: ir@resverlogix.com
Phone: 403-254-9252
www.resverlogix.com