ILYPSA COMPLETES ENROLLMENT IN HYPERPHOSPHATEMIA TRIAL

Ilypsa has completed enrollment in its Phase II clinical trial of ILY101 in the U.S. ILY101 is a novel phosphate-binding agent for the treatment of hyperphosphatemia, a serious complication in patients with kidney disease on dialysis.

The ILY101 Phase II trial is a multicenter, randomized, dose-ranging study of 120 patients. The study is being conducted at 20 clinical centers nationwide and is designed to examine the efficacy and tolerability of ILY101 in patients with chronic kidney disease with hyperphosphatemia on hemodialysis.

Hyperphosphatemia is the result of an electrolyte disturbance and is characterized by abnormally elevated serum phosphate levels. Acute and chronic renal failure are often the causes of this condition, according to the company. Almost all patients with renal failure experience hyperphosphatemia at some point during the course of their disease.

ILY101 is a metal-free, non-absorbed polymeric drug designed for the selective binding and removal of phosphate anions from the gastrointestinal tract. ILY101 is being developed for the treatment of hyperphosphatemia in patients on dialysis, reducing the systemic absorption of dietary phosphate. The design of ILY101 has the potential to allow for substantially lower daily doses and improved patient acceptance and tolerability compared with other products in this class of drugs, the company said.