AMSTERDAM, Netherlands, and CALGARY, Alberta, August 29, 2023 - Resverlogix Corp. ("Resverlogix") (TSX:RVX) today announced that new guidelines published by the European Society of Cardiology (ESC) reflect unmet need in the reduction of cardiovascular risk in patients with type 2 diabetes, and highlight the opportunity for apabetalone to benefit this high-risk population. New emphasis on combining multiple drugs with proven cardiovascular benefits mirrors Resverlogix’s therapeutic strategy – developed at the request of the US FDA – of combining apabetalone with sodium-glucose cotransporter-2 inhibitors (SGLT2i) for its planned BETonMACE2 study.
The new ESC guidelines are published online: HERE.
- New ESC guidelines recommend the use of combination therapies such as glucagon-like peptide-1 receptor agonists (GLP-1 RA) along with SGLT2i, rather than one or the other – as is currently recommended.
- This change reflects the unmet need for cardiovascular risk reduction in patients taking GLP-1 RA – including AstraZeneca’s Bydureon (exenatide), Novo Nordisk’s Victoza (liraglutide) and Ozempic (semaglutide), and Eli Lilly’s Trulicity (dulaglutide) – or SGLT2i – including AstraZeneca’s Farxiga (dapagliflozin), Janssen’s Invokana (canagliflozin), and Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin).
- The guidelines’ authors noted that a recent meta-analysis of major cardiovascular outcome trails found 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.
“We have long believed that combining therapies can prove to be an effective strategy in reducing cardiovascular risk in the type 2 diabetes population and we are very encouraged to see that the ESC is emphasizing this combinatorial approach in their treatment guidelines,” said Donald McCaffrey, CEO at Resverlogix. “In BETonMACE, we saw a 63% hazard reduction in MACE and heart failure hospitalizations among patients treated with apabetalone, who were already taking an SGLT2i or DPP4i [dipeptidyl peptidase-4 inhibitor]. Once approved, we believe that apabetalone in combination with glucose lowering agents such as SGLT2i will further improve outcomes and benefit patients.”
BETonMACE2, Resverlogix’s planned, Phase 3, cardiovascular outcomes trial of apabetalone, in patients with type 2 diabetes who are taking SGLT2i, is expected to begin next year.
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).
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 BETonMACE, BETonMACE2, as well as to the potential role of apabetalone in the treatment of patients with cardiovascular disease, chronic kidney disease, 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.
For further information please contact: