Resverlogix Corp. has announced that new data on RVX-208 was presented at the ERA-EDTA Congress in London, England in a poster entitled: "Effects of RVX-208, a First-in-Class Epigenetic BET-Inhibitor, on Key Renal Parameters in Subjects with a History of CVD, and Chronic Kidney Disease (CKD); a Post-hoc Analysis of Patients from the ASSERT, SUSTAIN and ASSURE Clinical Trials."
Dr. Kam Kalantar-Zadeh, Professor and Chief, Division of Nephrology and Hypertension at University of California in Irvine and Los Angeles stated, "Selective BET inhibition via RVX-208 may represent a novel approach to CKD treatment. Analyses of the data from recent clinical trials suggest that RVX-208 significantly lowers serum alkaline phosphatase (ALP) and improves lipid parameters in patients with CKD. Together these new findings warrant additional clinical trials for target responder CKD and/or dialysis populations who have a high burden of cardiovascular disease and risk."
Dr. Kalantar-Zadeh examined the data and contributed to this abstract at ERA-EDTA. He has also contributed to additional abstracts that have been submitted for peer review presentation.
In the pooled analysis from the SUSTAIN and ASSURE trials (n=499), assessment of the metabolic biomarker ALP, revealed a significant reduction of -10.98% in all RVX-208 treated patients (n=331) compared to a reduction of -3.23% in placebo treated patients (n=168) (p<0.0001) at the combined time points of 24 and 26 weeks. In addition, several subgroup analysis were performed.
In patients with a history of diabetes, a significant reduction in ALP of -13.9% was observed in the RVX-208 treated group (n=127) compared to -4.49% in the placebo treated group (n=65) (p<0.0001). Further analysis was performed on patients with Chronic Kidney Disease (CKD), defined by an estimated glomerular filtration rate (eGFR) of below 60 mL/min/1.73 m2.
In this group, RVX-208 treated patients (n=35) had reduced ALP levels of -13.9% versus -6.28% in placebo (n=13) (p=0.008). In addition, following 6 months of RVX-208 treatment, an increase in eGFR of +3.4% (p=0.04 vs. baseline) in the RVX-208 treated group was observed compared to a decrease of -5.9% in the placebo group.