Keryx Biopharmaceuticals' diabetic nephropathy drug candidate Sulonex (sulodexide) failed in a late-stage clinical trial. The SUN-MICRO 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 per cent reduction in ACR relative to baseline ACR, or (ii) a 50 per cent 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.
Michael S. Weiss, the Company's Chairman and Chief Executive Officer, commented, "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 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 III trial before the end of the year."
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialisation of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing Zerenex (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes.