Keryx Biopharmaceuticals reported that the top-line results from its SUN-MICRO Phase 3 clinical trial of Sulonex (sulodexide) for the treatment of diabetic nephropathy has failed to meet the primary objective of the study, designed to increase the proportion of patients that achieve therapeutic success at six months as compared to placebo over background therapy of maximal doses of ACE-inhibitors.
The company said therapeutic success was defined as conversion from microalbuminuria to normoalbuminuria, as measure of albumin/creatinine ratio (ACR), with at least a 25 percent reduction in ACR relative to baseline ACR; or a 50 percent reduction in ACR relative to baseline ACR. In addition, in reviewing the mean changes in ACR over time, Sulonex and placebo appeared to be similar, the New York City-based Keryx said.
“We are all very disappointed with the outcome of this study. While this represents the end of one chapter for Keryx, it is not the end of Keryx. Drug development is inherently risky and, accordingly, we have spent the last several years building what we believe to be a promising product portfolio in the event our lead drug failed,” said Michael S. Weiss, chairman and CEO of Keryx.
“We plan to re-focus our primary efforts and resources on rapidly moving Zerenex forward for ESRD patients with hyperphosphatemia and Perifosine forward for cancer. Our goal is to have Perifosine in a pivotal program this year and be well into our Zerenex high-dose Phase 2 trial before the end of the year,” Weiss added.