BOSTON, Nov. 18, 2016 /PRNewswire/ -- Stealth BioTherapeutics ( Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today presented results from the EVOLVE trial, which demonstrated that a single dose of elamipretide prior to renal artery angioplasty and stenting procedures improved kidney function and blood flow for three months post-procedure. The data were presented as a late-breaking poster at the American Society of Nephrology (ASN) Kidney Week 2016 in Chicago.
"Patients undergoing renal angioplasty and stenting, intended to open up kidney arteries blocked by atherosclerosis, often fail to regain normal kidney function due to tissue damage during the procedure, possibly due to the sudden replenishment of oxygen to starved tissues," said Dr. Stephen Textor, the principal investigator for the trial. "The study results validate our preclinical findings and our underlying hypothesis that elamipretide may help prevent acute kidney injury by preserving mitochondrial function in cells and ultimately improve measures of kidney function in these patients." EVOLVE was a randomized, double-blind, placebo-controlled Phase 2a clinical trial that evaluated 14 patients ages 40 to 80 years who were scheduled for percutaneous transluminal renal angioplasty and stenting, a common procedure to enhance blood flow to the kidneys. Prior to the procedure, patients received a single intravenous dose of either elamipretide (0.05 mg/kg/hr; n=6) or placebo (n=8). The endpoints were a change in kidney function, blood flow and perfusion to the kidney. For patients who received elamipretide, renal function as measured by eGFR was significantly improved three months after the procedure (46.5 mL/min ± 15.0) versus baseline (40.7 mL/min ± 13.4; P<0.05). For those in the placebo group, eGFR did not significantly change (34.4 mL/min ± 9.5 at baseline vs. 37 mL/min ± 10.5 at three months).