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 SANTA CLARA, Calif. -- 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 phase 2 clinical trial Phase 2 study. See Phase study. 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 ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , 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 See count-key-data. 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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." About Hyperphosphatemia Hyperphosphatemia is the result of an electrolyte disturbance and is characterized by abnormally elevated serum phosphate levels. Acute and chronic renal failure chronic renal failure Chronic kidney failure Nephrology A slow decline in renal function, which may be 2º to chronic HTN, DM, CHF, SLE, or sickle cell anemia and, if extreme, leads to ESRD, mandating kidney dialysis; an abrupt decline in renal function may be 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 Morbidity and Mortality can refer to:
Total kidney failure; chronic kidney failure is diagnosed as ESRD when kidney function falls to 5-10% of capacity. Mentioned in: Chronic Kidney Failure end-stage renal disease patients. 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 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 NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :SMMX), Ilypsa has rapidly created non-absorbed polymeric phosphate and potassium binder compounds to treat chronic kidney disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is , 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. |
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