CALGARY, Alberta, October 04, 2023 - Resverlogix Corp. ("Resverlogix") (TSX:RVX) today announced the publication of a peer-reviewed article, entitled “Apabetalone, a Clinical-stage, Selective BET Inhibitor, Opposes DUX4 Target Gene Expression in Primary Human FSHD Muscle Cells” in the journal Biomedicines.
“The beneficial effect of apabetalone highlighted in these models of facioscapulohumeral muscular dystrophy in combination with the impressive clinical and safety data in metabolic diseases, present further evidence to support apabetalone’s potential benefit in the treatment of patients with this disease,” said Donald McCaffrey, President and CEO at Resverlogix. “This exciting program will be added to a growing list of our compassionate use efforts that include post COVID-19 conditions, vascular dementia and chronic kidney disease, in addition to our upcoming core program Phase 3 clinical trial, BETonMACE2.”
The article is published online HERE.
Publication Highlights Include:
- Facioscapulohumeral muscular dystrophy (FSHD) is one of the most prevalent muscular dystrophies, affecting hundreds of thousands of people worldwide, and there are currently no approved therapeutics.
- The disease is caused by the inappropriate expression of a specific protein, double homeobox 4 (DUX4) in patient’s muscle cells.
- DUX4 activation leads to cell death, inflammation, atrophy, and loss of muscle function.
- Cultured muscle cells from FSHD patients were used to evaluate the potential of apabetalone to counter the negative effects of DUX4 activation.
- Apabetalone treatment inhibited DUX4 activity and reversed its hallmark gene expression in these cells.
- Treatment with apabetalone also did not negatively affect the differentiation or viability of the muscle cells, important indicators of the drug’s safety.
“Currently available treatment options for FSHD lessen the burden of symptoms, but do nothing to address the disease’s root cause,” said Dr. Ewelina Kulikowski, Chief Scientific Officer at Resverlogix. “By directly inhibiting DUX4 activity in muscle cells, apabetalone has the potential to significantly improve the lives of FSHD patients.”
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 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 representing a new way to treat chronic disease. Apabetalone is the only drug of its class that is well tolerated for chronic administration, with an established safety record in human clinical trials, including over 4200 patient-years of safety data across ten trials.
Apabetalone is the first therapy of its kind to receive Breakthrough Therapy Designation from the US Food & Drug Administration for a major cardiovascular indication following the ground-breaking findings from its Phase 3 study, BETonMACE. Data from this trial showed apabetalone may prevent major adverse cardiac events among high-risk cardiovascular disease patients who also have type 2 diabetes mellitus.
Founded in 2001, Resverlogix is a Calgary based late-stage biotechnology company and the world leader in epigenetics, 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 post COVID-19 conditions.
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 cardiovascular disease, post COVID-19 conditions, and pulmonary arterial hypertension in Canada and the United States.
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 potential role of apabetalone in the treatment of patients with facioscapulohumeral muscular dystrophy, cardiovascular disease, chronic kidney disease, vascular dementia, COVID-19, post COVID-19 conditions, 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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