Keryx reports positive phase 2 trial results for KRX-101 for treatment of diabetic nephropathy

New York, Nov. 11 - Keryx Biopharmaceuticals, Inc. said its phase 2 trial of KRX-101 (sulodexide gelcaps) showed positive results for the treatment of type 2 diabetic nephropathy patients with persistent microalbuminuria.

"We are very excited by these final efficacy data from our phase 2 study. We are extremely pleased that despite the relatively modest size of the study, we achieved a statistically significant benefit in the 200mg group over placebo for the protocol defined patients with microalbuminuria and demonstrated a very strong trend, nearing statistical significance, in the intent to treat population," said Michael Weiss, Keryx's chairman and chief executive officer in a news release.

"These results confirm our belief that KRX-101 is an active agent in the treatment of diabetic nephropathy and gives us a high degree of confidence that we will be successful in our phase 3 and 4 pivotal program."

In the study, patients were treated with KRX-101 or placebo for six months and followed for an additional two months post-treatment. Patients were randomized 1:1:1, placebo, 200mg and 400mg of KRX-101.

The primary endpoint was the percentage of patients achieving "Therapeutic Success" at six months.

A patient is considered a "Therapeutic Success" if after six months there is either: a 50% reduction in albumin to creatinine ratio, a standard measurement used to assess the level of kidney disease in these patients; or normalization of albumin to creatinine with at least a 25% reduction in albumin to creatinine .

The same endpoints will be used for the phase 3 clinical trial now recruiting patients.

There were no serious adverse events that were deemed by the investigators to be related, probably related or possibly related to the study drug. A full analysis of the safety database will be conducted in the coming months.

The results were presented Friday at the American Society of Nephrology's Renal Week conference in Philadelphia.

Keryx is a New York-based pharmaceutical company.

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