Ilypsa, Inc. Completes Enrollment of Phase 2 Clinical Trial of ILY101 for Patients with Chronic Kidney Disease on Hemodialysis: Multi-Center Study Evaluating Safety and Efficacy of Ilypsa's Non-Absorbed Polymeric Drug for Hyperphosphatemia
- Category: Small Molecules
- Published on Wednesday, 07 February 2007 02:00
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SANTA CLARA, CA, USA | Feb 06, 2007 | Ilypsa, Inc., a privately-held biopharmaceutical company pioneering novel non-absorbed drugs for renal disorders, announced today that it has completed enrollment of the company’s Phase 2 clinical trial of ILY101 in the United States. 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 2 trial is a multi-center, 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 CKD with hyperphosphatemia on hemodialysis.
“We are very pleased to have completed enrollment in this Phase 2 study for ILY101, our lead clinical candidate. We are encouraged with the progress of the program and are looking forward to taking this to the next stage of development,” said Jay Shepard, President and CEO of Ilypsa. “This rapid progress in the clinical development of ILY101 exemplifies the short development timelines inherent to our technology, as we have gone from IND to completion of ILY101 Phase 2 enrollment in just one year. ”
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. Almost all patients with renal failure experience hyperphosphatemia at some point during the course of their disease. Hyperphosphatemia can result in significant morbidity and mortality in end-stage renal disease patients.
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 in comparison to other products in this class of drugs.
About Ilypsa, Inc.
Ilypsa, Inc. is a privately held biopharmaceutical company discovering and developing a pipeline of next-generation renal care pharmaceutical products. Pioneering the use of a proprietary high throughput discovery and development platform created and validated at Symyx Technologies, Inc. (NASDAQ: SMMX), Ilypsa has rapidly created non-absorbed polymeric phosphate and potassium binder compounds to treat chronic kidney disease, and has additional programs in kidney, infectious and metabolic diseases. To date, Ilypsa has raised $46 million in a Series A and Series B round of financing. Investors include The Sprout Group, 5AM Ventures, US Venture Partners, Johnson & Johnson Development Corporation and Delphi Ventures. For more information, please visit www.ilypsa.com.
SOURCE: Ilypsa, Inc