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Atherosclerosis Drug Shows Promise in Mid-Stage Studies
New data have been reported from an ongoing analysis of the SUSTAIN and ASSURE trials in atherosclerotic patients with a high risk for recurrent events. This analysis focused on the ability of RVX-208 (Resverlogix Corp.), a first-in-class bromodomain and extra-terminal domain (BET) inhibitor, to affect major adverse cardiac events (MACE) over 6 months of treatment.
When the MACE data from SUSTAIN and ASSURE trials (N = 499) were combined, the findings demonstrated that treatment with RVX-208 led to a significant reduction in MACE. A total of 331 patients with atherosclerosis were treated with RVX-208, and 168 received placebo. Patients in the RVX-208 group showed a lower rate of cumulative events compared with those in the placebo group (6.74% vs. 15.09%, respectively; P = 0.02). Further, in a subgroup with elevated levels of C-reactive protein (greater than 2.0 mg/dL; n = 283), RVX-208 showed a significantly greater benefit than placebo, with cumulative event rates of 6.42% and 20.53%, respectively (P = 0.007).
RVX-208 is a first-in-class small molecule that inhibits BET bromodomains. The drug functions by removing atherosclerotic plaque via reverse cholesterol transport (RCT), the natural process through which atherosclerotic plaque is transported out of the arteries and removed from the body by the liver. RVX-208 increases the production of apolipoprotein A-I, the key building block of functional high-density lipoprotein (HDL) particles and the type required for RCT. These newly produced, functional HDL particles are flat and empty and can efficiently remove plaque and stabilize or reverse atherosclerotic disease.
Source: Resverlogix; January 15, 2013.