Keryx, FDA Finalize SPA Agreement for KRX-101 Phase III, IV Trials

Keryx Biopharmaceuticals has finalized a special protocol assessment (SPA) agreement with the FDA for the Phase III and Phase IV clinical trials of KRX-101, the company's drug candidate for the treatment of diabetic nephropathy.

The clinical plan to support a new drug application (NDA) approval for KRX-101 (sulodexide gelcaps) under accelerated approval consists of the following: (i) a single Phase III trial in patients with microalbuminuria based on the surrogate marker of regression of microalbuminuria as the primary endpoint; (ii) supportive data from previously conducted clinical studies; and (iii) substantial recruitment into the Phase IV confirmatory study that will measure clinical outcomes in patients with overt nephropathy, or macroalbuminuria.

The company plans to commence the Phase IV trial at approximately the same time as the start of the Phase III trial. The SPA process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for an NDA.