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Ilypsa Completes Phase 1 Clinical Trial of ILY101 for Hyperphosphatemia Associated With Chronic Kidney Disease

Posted on: Thursday, 20 April 2006, 09:00 CDT

Ilypsa, Inc., pioneering next-generation non-absorbed polymeric drugs for renal and metabolic disorders, today announced it has completed a Phase 1 clinical trial for ILY101, a novel phosphate binding agent that is being developed for the treatment of hyperphosphatemia, a serious complication in patients with chronic kidney disease (CKD) on dialysis.

The Phase 1 study examined the safety and tolerability of single and multiple doses of orally-administered ILY101 in twenty-four healthy volunteers. With the successful completion of Phase 1, the company expects to initiate a Phase 2 study in CKD patients on dialysis.

"We are very pleased to have successfully completed our first trial in humans. ILY101 is a compound discovered in-house that we expect to quickly advance to proof of concept in humans. Our progress into Phase 2 clinical trials in the next several months is in line with Ilypsa's expectations for faster and lower risk development of non-absorbed polymeric drugs," said Jay Shepard, President and CEO of Ilypsa.

"Hyperphosphatemia is a serious disease characterized by abnormally elevated serum phosphate levels that can result in significant morbidity and mortality in end-stage renal disease patients," noted Detlef Albrecht, M.D., Ilypsa's Chief Medical Officer. "We are very encouraged by the outcome of our Phase 1 study, and believe that ILY101 has the potential to offer an improved treatment option to patients who require chronic phosphate binder therapy."

About ILY101

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 CKD patients on dialysis and works by reducing the systemic absorption of dietary phosphate. ILY101 is designed to allow for 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 pharmaceutical products to treat renal and metabolic diseases. Pioneering the use of a proprietary high throughput discovery and development platform created and validated at Symyx Technologies, Inc. (Nasdaq: SMMX), Ilypsa has rapidly generated non-absorbed polymeric phosphate and potassium binding compounds that are being developed to treat chronic kidney and metabolic diseases. To date, Ilypsa has raised $46 million in Series A and Series B financing rounds. Lead investors include NLV Partners, 5AM Ventures, US Venture Partners, Johnson & Johnson Development Corporation and Delphi Ventures. For more information, please visit www.ilypsa.com.

Source: Business Wire

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