Resverlogix also advances its Fabry Disease indication data and planning
CALGARY, Alberta, March 18, 2019 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX: RVX) today announced the advancement of a $2.9 million project led by academic collaborators at Quebec Heart and Lung Institute, Laval University, to research the clinical potential of its lead drug apabetalone as a potential therapy for pulmonary arterial hypertension (“PAH”); key aspects of this phase 2 clinical study will be the assessment of safety and efficacy in this patient population.
The project has received prestigious funding by the Canadian Institutes of Health Research (“CIHR”), through an operating grant, and is matched by the Company including both in-kind and direct investment. The project is expected to initiate following completion of an already planned pilot study to begin in the first half of 2019.
Previous studies have demonstrated strong evidence of a role for the epigenetic reader, bromodomain and extra-terminal domain protein 4 (BRD4), in PAH disease progression, whereas BRD4 inhibition has been shown to reverse PAH in several animal models. To further understand its therapeutic potential, apabetalone has been successfully tested in both cellular and animal models of PAH and shown to impact disease progression, laying the foundation for the CIHR grant and planned clinical study. PAH is a progressive and multifactorial condition characterized by the chronic elevation of pulmonary artery pressure leading to right ventricular failure. In spite of recent advances in understanding the pathophysiology and approved therapies, PAH remains a serious disease with significant morbidity and mortality.
Resverlogix also continues to develop its previously announced interest in Fabry Disease, an orphan indication. The company is pleased to announce that it is advancing its clinical program in Fabry Disease with support from in-house research and development. A preclinical, ex vivo study, examining the effect of apabetalone on primary blood cells taken directly from Fabry Disease patients, is currently underway.
Apabetalone, an orally available small molecule BET (bromodomain and extra-terminal) inhibitor, is currently completing testing in a global Phase 3 clinical trial – BETonMACE – focused on high-risk cardiovascular disease patients with type 2 diabetes mellitus and low levels of high-density lipoprotein (HDL). The independent Data and Safety Monitoring Board has completed eight planned safety reviews for BETonMACE and recommended the study continue without modification.
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. BET bromodomain 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 funding by CIHR, and matched by the Company, of a clinical phase 2 trial assessing the safety and efficacy of apabetalone in PAH patients, the timing of this phase 2 trial and the associated pilot study, the advancement of a Fabry Disease clinical program 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, 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.