Multinational Research Collaboration Advances Apabetalone Towards Phase 2 Clinical Trial for PAH Patients
CALGARY, Alberta, May 06, 2019 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today the recent publication of an article titled: “Multicenter Preclinical Validation of BET Inhibition for the Treatment of Pulmonary Arterial Hypertension” in the high-impact, peer-reviewed medical journal, American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society. A Phase 2 clinical trial – studying apabetalone as a potential therapy for pulmonary arterial hypertension (PAH) – is expected to initiate following completion of an already planned pilot study to begin in the first half of 2019.
“We are extremely pleased that our collaborative work resulted in this high-profile publication highlighting the potential of apabetalone and BET inhibition in the treatment of PAH and other diseases,” said Dr. Ewelina Kulikowski, Senior Vice President, Research & Development of the Company. “Significantly, each independent, yet complementary, study showed treatment efficacy in animal models of this disease. We look forward to advancing this work in a phase 2 PAH trial later this year. On behalf of Resverlogix, I’d like to thank our collaborators, Drs Sebastien Bonnet and Steeve Provencher, and look forward to future opportunities where industry and academia can truly leverage their respective strengths to advance treatments into new therapeutic areas.”
AJRCCM Publication Highlights include:
- Bromodomain and extra-terminal domain protein 4 (BRD4), a bromodomain and extra-terminal (BET) protein, is upregulated in the remodeled pulmonary vasculature of PAH patients
- Apabetalone is a BET inhibitor in clinical development for cardiovascular and renal disease
- Various animal and cell models of PAH were used to explore the therapeutic potential of apabetalone in treating this disease
- Apabetalone treatment resulted in reduced inflammation and normalized the rapid cell growth and resistance to cell death that occurs in cells taken from PAH patients
- Apabetalone reversed vascular remodeling, a hallmark feature of PAH, and improved measurements of pulmonary function in diverse animal models
Publication Background and Conclusions:
Apabetalone is an inhibitor of BET proteins, which has been shown in a number of applications to target BRD4. In previous clinical trials, apabetalone reduced the incidence of major adverse cardiac events (MACE) by up to 62% in various cardiovascular disease patient populations. Apabetalone also had a highly favourable safety profile in these patients.
Preclinical trials in the area of PAH have shown that BRD4 plays a major role in the pathophysiology of PAH, and that BRD4 inhibition can alleviate many aspects of the disease. With the support of Resverlogix, a multinational collaboration of research labs examined the effects of apabetalone in preclinical models of PAH. Results from the independent studies consistently demonstrated that apabetalone reversed vascular remodeling in multiple complementary animal and cellular models of PAH and could be combined safely with current PAH therapy. These studies provide the basis for the initiation of a phase 2 clinical trial aimed at determining the safety of apabetalone use in PAH patients.
The publication can be viewed using the following LINK.
PAH Progression and Clinical Trial
PAH is a progressive and multifactorial condition characterized by the chronic elevation of pulmonary artery pressure leading to right ventricular failure; it remains a serious disease with significant morbidity and mortality.
The Company recently announced the advancement of a $2.9 million, phase 2 trial led by academic collaborators at Quebec Heart and Lung Institute, Laval University, to research the clinical potential of apabetalone as a potential therapy for PAH; key aspects of this study will be the assessment of safety and efficacy in this patient population. The project is expected to initiate following completion of an already planned pilot study to begin in the first half of 2019.
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. BET inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases, while maintaining a well described safety profile.
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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 relating to the initiation / completion of a PAH pilot and Phase 2 clinical trial and the potential role of apabetalone in the treatment of CVD, DM, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, PAH and Orphan 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.