REDWOOD CITY, Calif., Feb. 4, 2014 (GLOBE NEWSWIRE) -- Relypsa, Inc. (Nasdaq:RLYP), a clinical-stage biopharmaceutical company, today announced that patient enrollment for its Phase 1 onset-of-action trial of patiromer for the treatment of hyperkalemia has been completed. This is the final clinical trial that Relypsa expects to include in its New Drug Application (NDA), planned to be filed with the U.S. Food and Drug Administration (FDA) during the third quarter of 2014.
The open-label, single arm trial enrolled 25 patients and is designed to evaluate the time-to-onset of the potassium-lowering action of patiromer in patients with hyperkalemia. The trial design includes a three-day run-in period to control the dietary intake of potassium followed by a 48-hour treatment period and a 7-day post-treatment safety follow-up period. The change from baseline in serum potassium levels is assessed at multiple time points during the 48-hour treatment period. Relypsa expects to complete its analysis and announce data from the trial in the first half of 2014.
According to Lance Berman, MD, Chief Medical Officer, "We look forward to understanding how quickly we can expect to see the potassium-lowering effects of patiromer. This clinical trial should provide valuable information to help physicians better understand when patiromer starts lowering serum potassium levels."
About Hyperkalemia and Patiromer
Hyperkalemia, a life-threatening condition defined as abnormally elevated levels of potassium in the blood, is frequently prevalent in patients who suffer from renal impairment, hypertension, diabetes and/or heart failure. Hyperkalemia can lead to cardiac arrhythmia and sudden death. Patients with chronic kidney disease or heart failure are at particular risk for developing hyperkalemia, especially those treated with RAAS inhibitors such as ARBs (Angiotensin Receptor Blockers), AAs (Aldosterone Antagonists), and ACE (Angiotensin-Converting-Enzyme) Inhibitors. Although RAAS inhibition has been shown to protect kidney and cardiac function, many patients who could benefit from RAAS inhibitors are untreated or undertreated due to the undesirable side effect of increasing serum potassium.
Patiromer (RLY5016 for Oral Suspension) is a high capacity non-absorbed oral potassium binder being developed for the treatment of hyperkalemia.
About Relypsa, Inc.
Relypsa, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of non-absorbed polymeric drugs to treat disorders in the areas of renal, cardiovascular and metabolic diseases. The Company's two-part pivotal Phase 3 trial of its lead product candidate, patiromer, for the treatment of hyperkalemia, a life-threatening condition defined as abnormally elevated levels of potassium in the blood, has been completed and the primary and secondary endpoints were met. Relypsa has global royalty-free commercialization rights to patiromer, which has intellectual property protection in the U.S. until at least 2030. More information is available at www.relypsa.com.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Relypsa, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including its expectations regarding (i) the clinical trials to be included in its NDA for patiromer, (ii) the timing of the submission of its NDA for patiromer, (iii) the timing of completing its analysis and announcing data from its Phase 1 onset-of-action trial and (iv) the value of the information it expects to receive from the trial relating to the timing of when patiromer starts lowering serum potassium levels. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of our regulatory filings, our substantial dependence on patiromer and other matters that could affect the availability or commercial potential of our drug candidate. Relypsa undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Relypsa's prospectus filed with the Securities and Exchange Commission on November 15, 2013, and its future periodic reports to be filed with the Securities and Exchange Commission.