Resverlogix Corp. 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.

Key Guidelines. 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'sVictoza (liraglutide) and Ozempic (semaglutide), and Eli Lilly's Trulicity (dulaglutide) - or SGLT2i - including Astra Zeneca'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. 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. 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 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.