Keryx Suffers Setback As Diabetic Nephropathy Candidate Fails Phase III Study
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm falls back on mid-stage pipeline candidates in chronic kidney disease, kidney cancer.
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Keryx Biopharmaceuticals' late-stage diabetic nephropathy treatment Sulonex (sulodexide) failed to show a benefit in clinical studies, the firm revealed March 7. Top-line data from the Phase III SUN-MICRO trial showed Sulonex was no better than placebo at slowing kidney breakdown over time as measured by the level of the protein albumin in the urine, a condition called microalbuminuria, the company said. The study enrolled type 2 diabetics with persistent microalbuminuria and added 200 mg daily of Sulonex or placebo to a background regimen of blood pressure medicine (an ACE inhibitor or angiotensin receptor blocker). The goal was to achieve at least a 25 percent reduction in albumin/creatinine ratio, with an eye toward a 50 percent reduction (1 (Also see "Keryx Looks To Release Top-Line Sulonex Phase III Data Early Next Year" - Pink Sheet, 9 Mar, 2007.)). Michael S. Weiss, CEO of New York-based Keryx, maintained in a March 10 statement that while the failure of its lead product is a major disappointment, the company has a strong mid-stage pipeline fall back on. "While this represents the end of one chapter for Keryx, it is not the end of Keryx," he said. However, unlike Sulonex, the company's next-in-line candidates, Zerenex (ferric citrate) for hyperphosphatemia, and perifosine, an oral Akt inhibitor for renal cell carcinoma, would enter highly competitive markets. In a March 10 research note, JP Morgan small/mid-cap analyst Cory Kasimov downgraded his estimation of Keryx from a company likely to outperform its peers to one likely to perform at the same level in the next year. "We are currently skeptical about the potential of" Zerenex and perifosine, Kasimov said. "Moreover, we do not expect the value proposition for either product to materially emerge until 2009 at the earliest." Zerenex is on track to start a high-dose Phase II study in the first half of 2008. It would compete with Genzyme's sevelamer franchise ( Renagel and Renvela ) as well as Shire's Fosamax (lanthanum carbonate) and Fresenius' PhosLo (calcium acetate). Perifosine is expected to enter a pivotal Phase III RCC trial by mid-year, Kasimov said. According to Keryx, it is a novel, potentially first-in-class drug that modulates the Akt pathway. The Akt pathway frequently is activated in renal cell cancer, the firm notes, adding that perifosine also modulates other key signal transduction pathways, including JNK and MAPK, all associated with apoptosis, cell growth, differentiation and survival. -Shirley Haley ([email protected]) |