Resverlogix has exceeded the enrolment target of more than 2,400 patients in its Phase III BETonMACE trial, evaluating the effect of its drug, apabetalone, in Cardiovascular Disease (CVD) patients with type 2 Diabetes Mellitus (DM) and low high-density lipoproteins (HDL).
The pivotal trial enrolled its first patient in November 2015.
Its primary endpoint is to establish a relative risk reduction (RRR) of major adverse cardiac events (MACE), narrowly defined as a single composite endpoint of cardiovascular death, non-fatal myocardial infarction (MI) and stroke.
Secondary pre-specified objectives of the trial include the analysis of renal function and MACE in patients with chronic kidney disease (CKD) stage three as well as cognition, measured by the Montreal Cognitive Assessment (MoCA) in all patients aged 70 and over.
Resverlogix president and CEO Donald McCaffrey said: “Achieving full enrolment early leaves two major clinical reflection points that will transpire in 2018.
“The first will be attaining 75% of our targeted 250 MACE events, being 188 events in total, thus allowing us the ability to conduct a sample size re-estimation analysis assuring that the trial will be sufficiently powered to confirm relative risk reduction.
“The second major reflection point will be the most important, the Primary Endpoint read-out around the end of 2018. This read-out will prove pivotal in planning our FDA and EMA registration applications.”
Resverlogix said it is exploring the option of enrolling patients in the US for the BETonMACE trial.
It also intends to explore the option of relying on existing BETonMACE data to file a US New Drug Application (NDA) for apabetalone.
Apabetalone (RVX-208) is a small molecule that is a selective bromodomain and extra-terminal (BET) inhibitor.