Keryx says it will complete enrollment in phase 3 Sulonex trial in second half of the year

By Jennifer Lanning Drey

Eugene, Ore., June 27 - Keryx Biopharmaceuticals expects to complete enrollment in a 500-patient, phase 3 clinical registration trial for Sulonex, its lead product candidate for treatment of diabetic nephropathy, in the second half of the year, according to Michael Weiss, chief executive officer of the company.

Keryx expects to receive accelerated approval for the drug sometime in the first half of 2008, Weiss said at the Jefferies Life Sciences Conference on Tuesday.

The company also plans to simultaneously begin a larger phase 4 clinical trial of Sulonex that will involve about 2,200 patients and take between 26 and 36 months to recruit, he said.

The phase 4 clinical trial will follow patients until they have an event, such as going on kidney dialysis, and Keryx hopes to have data available from the study in the second half of 2010, Weiss said.

"Sulonex addresses a large, unmet medical need in the treatment of diabetic nephropathy. It has an attractive and novel mechanism of action, and we have a global phase 3 and phase 4 registration program underway, supported by compelling phase 2 data," said Weiss on Tuesday.

The phase 3 and phase 4 portions of the program are both randomized, double-blind, placebo-controlled study comparing a 200 mg daily dose of Sulonex versus a placebo in patients with persistent microalbuminuria.

"We'll have over 3,000 patients in clinical trials in our U.S.-based programs, so we'll get some more information, but to date, we feel very comfortable with the safety profile of this compound, Weiss said.

Sulonex has been on the market for about 20 years in Italy, and between 300,000 and 400,000 patients have been treated with the drug, Weiss said.

Keryx has a U.S. patent for Sulonex for the treatment of diabetic nephropathy that extends through 2017, he said.

New York City-based Keryx acquires, develops and commercializes novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer.

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