Numerous GLP-1 RA and SGLT2i presentations touted their clinical results, providing continued excitement for our BETonMACE program, which observed a non-prespecified 63% reduction in MACE and heart failure hazard among patients taking next-generation glucose lowering drugs
Calgary, Alberta--(Newsfile Corp. - September 3, 2024) - Resverlogix Corp. (TSX: RVX) ("Resverlogix" or "the Company") today announced its presentation at the European Society of Cardiology ("ESC") Congress 2024 in London, UK on September 1, 2024. Resverlogix's Chief Scientific Officer, Dr. Ewelina Kulikowski, gave a presentation entitled: "Epigenetic BET inhibitor apabetalone counters inflammatory and fibrotic processes in activated cardiac fibroblasts providing insight into reduced hospitalizations for heart failure in BETonMACE trial".
"The importance of the presentations at this year's ESC congress is that they position apabetalone as a drug with potential benefits across various metabolic diseases such as cardiovascular disease, chronic kidney disease, inflammation, & diabetes," said Donald McCaffrey, President & CEO of Resverlogix. "For the past several years Resverlogix has led the way in developing a program to tackle the underlying causes of these diseases, cross treatment boundaries, and - in conjunction with other treatments - deliver real benefits for patients. We were pleased to see other groups promote this combinatorial approach at this year's ESC event."
The conference featured presentations on next-generation glucose lowering drugs, such as sodium-glucose cotransporter-2 inhibitors ("SGLT2i") and glucagon-like peptide-1 receptor agonists ("GLP-1 RA"), focused on their additional cardiovascular benefits in diabetic and chronic kidney disease ("CKD") patients. Current ESC guidelines on the treatment of cardiovascular disease in diabetic patients reports a pooled 10% hazard reduction in major adverse cardiac events ("MACE"; a composite of cardiovascular death, heart attack, and stroke) with SGLT2i treatment, and a 15% MACE hazard reduction with GLP-1 RA treatment. Based on data from the Phase 3 trial, BETonMACE, apabetalone treatment reduced the hazard of MACE and hospitalization due to heart failure by 63% (p=0.0002), among patients taking next-generation glucose lowering drugs, in a post-hoc analysis.
"The data presented at the ESC Congress indicates that patients receiving the best currently available treatments still face significant risk of cardiovascular events," said Mr. McCaffrey. "Our Phase 3 results suggest that apabetalone and SGLT2 inhibitors - in combination - can further reduce the risk of events, and we believe we will conclusively demonstrate this in our upcoming BETonMACE2 trial."
In addition to Resverlogix's presentation on the benefit of apabetalone in cardiac remodeling - a key process in the prevention of heart failure, two oral presentations and two moderated posters - all submitted by independent researchers unaffiliated with the Company - featured research on apabetalone's potential benefits for vascular dysfunction, heart failure, cellular aging, and pulmonary arterial hypertension, respectively. These presentations showcased new evidence from animal models of heart failure showing positive apabetalone treatment effects, and they also provided important mechanistic insights connecting apabetalone's inhibition of bromodomain and extra-terminal domain ("BET") proteins to our clinically-observed benefits. Presentation details can be found on the ESC's scientific programme.
"We are excited to observe scientific research being presented by multiple independent groups on the potential benefits of apabetalone in the treatment of chronic disease," said Dr. Kulikowski. "This research recognizes the important role played by BET proteins in the epigenetic dysregulation that is a core driver of chronic disease. We see growing excitement around apabetalone's ability to counter this dysregulation through its epigenetic mechanism of action."
A scientific review, published online this month in Pharmacological Research, entitled: "Exploring the therapeutic potential of apabetalone in diabetic kidney disease: Bridging preclinical findings with clinical translation" also highlighted potential benefits of apabetalone for the treatment of diabetic kidney disease. The article can be found HERE.
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 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 across multiple human clinical trials, totaling over 4200 patient-years of safety data.
Cardiology:
Apabetalone is the first therapy of its kind to receive Breakthrough Therapy Designation from the US Food & Drug Administration for a major cardiovascular indication. This followed the ground-breaking findings from its Phase 3 study, BETonMACE, which showed apabetalone may 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, 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, 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 cardiovascular disease, diabetes, chronic kidney disease, post COVID-19 conditions,pulmonary arterial hypertension, aging, 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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