Keryx's Phase 3 Clinical Trial Of Sulonex For Diabetic Nephropathy Fails To Meet Primary Efficacy Endpoint - Update

(RTTNews) - Friday, New York - based Keryx Biopharmaceuticals, Inc. (KERX | news | PowerRating | PR Charts ) announced that Phase 3 clinical trial of Sulonex for the treatment of diabetic nephropathy failed to meet the primary objective. The trial was trying to establish the proportional increase of patients that achieve therapeutic success at 6 months as compared to placebo over background therapy of maximal doses of ACE-inhibitors or ARBs.

The company said therapeutic success of the trial was defined as conversion from microalbuminuria to normoalbuminuria, as measured by albumin/creatinine ratio, with at least a 25% reduction in ACR relative to baseline ACR or 50% reduction in ACR relative to baseline ACR.

Keryx expressed disappointment over the outcome of the study, however said "the result represents the end of one chapter for Keryx, it is not the end of Keryx." Further, the company said it plans to re-focus on primary efforts and resources on rapidly moving Zerenex forward for ESRD patients with hyperphosphotemia and Perifosine forward for cancer.

Looking ahead, Keryx plans to have Perifosine in a pivotal program this year and to focus on Zerenex high-dose Phase 2 trial before the end of the year.

KERX finished Friday's regular trade at $5.26, down $0.11 or 2.05% on a more than average volume of 1.467 million shares. In the after-trading session the shares declined $0.01 and traded at $5.25.

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