Resverlogix Plans COVID-19 Clinical Trial Program Launch
CALGARY, Alberta, June 01, 2020 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX:RVX) is pleased to announce that it is moving forward with a plan to further evaluate apabetalone’s impact on COVID-19 in both a preclinical and clinical setting. A first step will be to investigate whether apabetalone treatment of human cells susceptible to 2019 novel coronavirus (2019-nCoV) infection will impact the replication cycle of the virus. Initial work – undertaken in an approved Biological Safety Level 3 laboratory (BSL3) – has commenced with additional work with other third-party laboratories expected to follow soon. In parallel, cell factors critical to 2019-nCoV infection will be assessed in-house for apabetalone-mediated regulation.
An additional step will be to proceed with an open-label study to assess the safety and efficacy of a clinical course of oral apabetalone in hospitalized subjects with 2019-nCoV infection on top of standard of care compared to standard of care alone. Endpoints will include clinical progression, an evaluation of viral levels via nasal and pharyngeal swabs, as well as the effect of apabetalone on key virus-related biomarkers including ACE2 and others within the renin-angiotensin system, as well as an inflammatory panel of markers including IL6, IL8, CRP, etc. in hospitalized subjects with 2019-nCoV infection.The safety of apabetalone has been demonstrated in >1900 subjects in completed Phase 1, Phase 2 and Phase 3 clinical studies, including >1700 patients with cardiovascular disease. Overall, apabetalone was generally well tolerated and serious adverse events were similar in placebo and active-treated subjects.The Company’s interest in COVID-19 research is a direct result of studies published by Gordon, D.E. et al. in Nature (2020) ‘A SARS-CoV-2 protein interaction map reveals targets for drug repurposing’ (https://doi.org/10.1038/s41586-020-2286-9) that demonstrated apabetalone to inhibit specialized proteins – called bromodomain and extra terminal domain (BET) proteins – from interacting with a SARS-CoV-2 viral protein, with potential for limiting viral reproduction in human cells. This is in addition to work done, in house, that demonstrated that apabetalone treatment of human cells decreases the expression of the key viral adhesion protein, ACE2.Additional interested COVID-19 collaborators, including investigators/clinicians, with BSL3 lab facilities can contact:Donald McCaffrey, President & CEO
1-587-390-7888About ResverlogixResverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. Apabetalone is the first therapy of its kind to have been granted US FDA Breakthrough Therapy Designation – for a major cardiovascular indication – to help facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy.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.Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).Follow us on:Twitter: @Resverlogix_RVXLinkedIn: https://www.linkedin.com/company/resverlogix-corp-/For further information please contact:Investor Relations
Or visit our website: www.resverlogix.comThis 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 launch of a COVID-19 clinical trial program and the various steps of such a program including work performed in a BSL3 laboratory – with additional work with other third-party laboratories to follow – and other in-house laboratory activities, the initiation of an open-label study to assess the safety and effect of a clinical course of oral apabetalone in hospitalized subjects with 2019-nCoV in addition to standard of care and the potential role of apabetalone in the treatment of patients with COVID-19, cognitive disorders, high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, Fabry disease, peripheral artery disease and other 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.