The poster for the Resverlogix abstract below from AHA 2018 is now posted to the Resverlogix website. Poster has more detail than what was in the abstract.

November 11, from 10:30 AM to 11:45 AM CST: "Cardiovascular Evaluation of the Selective BET Inhibitor, Apabetalone, in ACS Patients With Diabetes: Baseline Characteristics of the BETonMACE CV Outcomes Study." 

Abstract

Introduction: Vascular perturbation in acute coronary syndrome (ACS) is linked to inflammation. Bromodomain and extraterminal (BET) proteins coordinate gene transcription following inflammatory insult. Apabetalone (ABL) selectively inhibits binding between BET proteins and acetyl-lysine marks on histone tails reducing the effects of inflammation. Post-hoc analysis of phase IIb trials with ABL demonstrated a 55% RRR in major adverse cardiac events (MACE) in patients with coronary heart disease , with more pronounced benefit among patients with diabetes (DM) and low HDL cholesterol (HDL-C).
Hypothesis: BETonMACE is the first Phase III cardiovascular (CV) outcome study with a BET inhibitor. It tests the hypothesis that ABL reduces MACE in patients with T2D, recent ACS, and low HDL-C.
Methods: At 195 centers in 13 countries, BETonMACE includes patients with ACS during the preceding 7-90 days, DM, HDL-C <40 mg/dL (males) or <45 mg/dL (females), and treatment with atorvastatin 40-80 mg, rosuvastatin 20-40 mg daily, or the maximum tolerated dose of these agents. Qualifying patients were randomized 1:1 to treatment with ABL 100 mg orally twice daily or placebo. The primary endpoint is time to first occurrence of CV death, non-fatal myocardial infarction or stroke. The trial will continue until at least 250 patients have a primary endpoint. With an assumed event rate of 10.5% in the placebo group over 1.5 years, 2400 patients provide 80% power to detect a 30% reduction in MACE with ABL.
Results: Enrollment of 2418 patients was completed on Mar 6, 2018. Baseline characteristics include: male sex 74.5%; mean age 61 (SD 9.5) years; median (interquartile range) LDL-C 65.0 (36) mg/dL, HDL-C 33.0 (7) mg/dL, HbA1c 7.3 (2.3) %, and blood pressure 129/76 mmHg; eGFR<60 ml/min 11%; treatment with atorvastatin (40/80mg) or rosuvastatin (20/40mg) 91.6%; dual anti-platelet therapy 85%; index ACS event MI 75% ; coronary revascularization for index ACS 78%; and median time from index ACS to randomization 34 days.
Conclusions: BETonMACE is a unique proof-of-concept trial that will determine if selective BET inhibition with ABL, added to evidence-based treatments, reduces MACE in high-risk patients with DM, recent ACS, and low HDL-C. Results are expected early 2019.