BETonMACE is the first ever Phase 3 trial of a BET inhibitor, outside of oncology. Completed in September 2019, the trial was designed to evaluate the safety and efficacy of apabetalone in preventing Major Adverse Cardiac Events (MACE) in high-risk, cardiovascular disease patients with type 2 diabetes mellitus.
Frequently Asked Questions
Apabetalone is an entirely new epigenetic therapeutic, taken orally to improve the condition of people suffering from vascular diseases by lowering the expression of disease-related genes.
Expression of these genes promotes disease progression in patients suffering from vascular disease and diabetes, damaging arteries and increasing their risk of heart attacks and strokes.
Apabetalone prevents specialized proteins – called bromodomain and extraterminal domain (BET) proteins – from activating the expression of disease-associated genes, thereby normalizing expression towards a healthier state.
BETonMACE is a Phase 3 clinical trial designed to study apabetalone’s prevention of Major Adverse Cardiac Events (heart attack, stroke, or cardiac death) in high-risk diabetes patients with a recent history of cardiovascular disease.
BETonMACE, initiated in 2015, included 2,425 patients in 13 countries. The trial was completed in September 2019 with results being presented at the AHA meeting in Philidelphia in November 2019. The addition of apabetalone to standard of care therapy after acute coronary syndrome in patients with T2DM and low HDL cholesterol, although not reaching statistical significance, showed a strong trend towards a reduction in MACE.
With the exclusion of undetermined deaths from MACE this trend was clearer. A consistent trend was seen for the CV death and non-fatal myocardial infarction components providing evidence for the potential reduction in these events by 20% in just over two years. The prespecified secondary endpoint of first CHF admission was reduced by 41% with apabetalone. When CHF was added to the primary endpoint post hoc, a reduction of 23% was seen.
Despite maximized use, current standard of care (statins) only prevents approximately 30% of cardiovascular events within the BETonMACE patient group; the remaining 70% represents a significant addressable market for the company. When used in combination with current treatments, apabetalone has the potential to improve the quality and duration of these patients’ lives.
Apabetalone's safety track record was further strengthened with a clear safety profile in BETonMACE. The drug was well tolerated in the study with similar incidence of adverse events and serious adverse events as placebo. The study passed 9 reviews from an independant, third-party data safety monitoring board (DSMB) during its conduct.