Resverlogix Corp. announced the commencement of a phase 3 clinical trial called 'BETonMACE' with lead drug apabetalone (RVX-208) in high-risk patients with coronary artery disease (CAD) and type 2 diabetes mellitus (DM).
Resverlogix has received initial approval from the regulatory authority and ethics committee in the first three countries: Belgium, Hungary and Israel, which will represent approximately 15 investigative sites of an expected 175 site trial. The first site initiation visit was held yesterday and with drug now available to the centers, enrollment of patients will commence. Over the course of the coming months, additional investigative sites will be activated.
BETonMACE will assess the effect of apabetalone (RVX-208) on time to first occurrence of major adverse cardiovascular events (MACE) in high-risk type 2 DM patients with CAD. The Phase 3 trial will be double-blinded, randomized, parallel group, placebo-controlled, with up to 104 weeks of dosing. MACE is defined as cardiovascular death, non-fatal myocardial infarction (MI), hospitalization for cardiovascular disease events or stroke. All subjects will remain on a high-dose statin therapy (atorvastatin or rosuvastatin), with the experimental group receiving 200 mg/day of apabetalone in the form of 100 mg capsules twice daily. Primary outcome measures will be time to first occurrence of MACE as defined above.
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor.