Phase IIb study of RVX 208 (Resverlogix) fails to meet primary endpoint in Dyslipidaemia
The Phase IIb ASSURE clinical trial evaluating RVX 208, from Resverlogix, in high-risk cardiovascular patients with low high-density lipoprotein (HDL) did not meet its primary endpoint of a -0.6% change in percent atheroma volume as determined by intravascular ultrasound (IVUS). The ASSURE study randomised 324 patients to receive RVX-208 or placebo. The RVX 208 treated group had -0.4% plaque regression (p= 0.08).
However the patient group receiving active treatment met the secondary endpoints of regression of total (coronary) atheroma volume (TAV) and increases in Apolipoprotein A-I (ApoA-I) and HDL cholesterol. The company states that unexpected strong placebo results will need to be further explored. RVX 208 increases production of ApoA-I, the key building block of functional high-density lipoprotein (HDL) particles.
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