Keryx Announces Positive Interim Results From Phase II Study of KRX-101

Keryx Biopharmaceuticals has reported interim data from the Phase II study titled, "An exploratory, randomized, double-blind, multiple dose study of KRX-101 (sulodexide gelcaps) for the treatment of Type 2 diabetic nephropathy patients with persistent microalbuminuria."

The Phase II study, which is currently ongoing, compares two doses of KRX-101 (200 mg and 400 mg) versus placebo in patients with diabetic microalbuminuria who are receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker as background therapy.

In this study, patients are treated with KRX-101 or placebo for six months and followed for an additional two months post-treatment. The primary endpoint for the study is "therapeutic success" of the two active arms combined versus placebo at six months. Therapeutic success is a binary composite endpoint defined as conversion from microalbuminuria to normoalbuminuria (with at least a 25 percent reduction in microalbuminuria) as measured by albumin/creatinine ratio (ACR), or at least a 50 percent reduction in ACR level relative to baseline.