Keryx Biopharmaceuticals Announces that the SUN-MICRO Phase 3 Clinical Trial Failed to Meet its Primary Efficacy Endpoint
Keryx Biopharmaceuticals, Inc. announced top-line results from its SUN-MICRO Phase 3 clinical trial of Sulonex (sulodexide) for the treatment of diabetic nephropathy. The Company announced that this Phase 3 clinical trial failed to meet the primary objective of the study, which was to increase the proportion of patients that achieve therapeutic success at 6 months as compared to placebo over background therapy of maximal doses of ACE-inhibitors or ARBs. Therapeutic success was defined as (i) conversion from microalbuminuria to normoalbuminuria, as measured by albumin/creatinine ratio (ACR), with at least a 25% reduction in ACR relative to baseline ACR, or (ii) a 50% 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.
"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. We plan to re-focus our primary efforts and resources on rapidly moving Zerenex forward for ESRD patients with hyperphosphotemia 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."
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