REDWOOD CITY, Calif., March 16, 2015 (GLOBE NEWSWIRE) -- Relypsa Inc. (Nasdaq:RLYP), a biopharmaceutical company, today highlighted multiple data presentations of Patiromer for Oral Suspension (FOS) at the 2015 World Congress of Nephrology. Patiromer FOS, Relypsa's lead product candidate, is an oral potassium binder being developed for the treatment of hyperkalemia.
The data presented at the meeting demonstrated consistent safety and efficacy of Patiromer FOS across multiple studies and were included in Relypsa's New Drug Application (NDA) for Patiromer FOS that was accepted by the U.S. Food and Drug Administration (FDA) in December 2014. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 21, 2015 for completion of the review of the NDA for Patiromer FOS.
"Relypsa's NDA for Patiromer FOS is supported by a package of robust clinical data from eight clinical studies," said Lance Berman, M.D., chief medical officer of Relypsa. "Patiromer FOS has performed consistently in terms of both safety and efficacy across all studies, including across multiple disease and patient sub-groups."
2015 World Congress of Nephrology Poster Presentations:
- Patiromer For Oral Suspension Reduced Serum K[plus] and Maintained Normokalemia in CKD Patients with Moderate-to-Severe Hyperkalemia on RAAS Inhibitors in the OPAL-HK Study (Weir, et al; Poster #217)
- Mechanism of Action of Patiromer For Oral Suspension: Increases Fecal K[plus] Excretion in Health Subjects Independent of Race (Epstein, et al; Poster #218)
- Attainment of Normokalemia in Patients With Chronic Kidney Disease and Moderate to Severe Hyperkalemia on RAAS Inhibitors: Clinical Trial Results With Patiromer (Epstein, et al; Poster #219)
- Patiromer For Oral Suspension Produces Prompt and Sustained Reductions in Serum K[plus] in CKD Patients with Moderate-to-Severe Hyperkalemia on RAAS Inhibitors (Epstein, et al; Poster #220)
Hyperkalemia, a serious condition defined as abnormally elevated levels of potassium in the blood, is frequently prevalent in patients who suffer from chronic kidney disease, hypertension, diabetes and/or heart failure. Hyperkalemia can lead to life-threatening cardiac arrhythmia and sudden death. Patients with chronic kidney disease or heart failure are at particular risk for developing hyperkalemia, especially those treated with renin-angiotensin-aldosterone-system (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.
About Patiromer FOS
Patiromer FOS is an oral potassium binder being developed for the treatment of hyperkalemia. The compound has been evaluated in CKD patients with hyperkalemia, including a two part Phase 3 program, a 12-month Phase 2 trial and a 48-hour Phase 1 onset-of-action trial. In all of those trials, Patiromer FOS met its efficacy endpoints and the treatment was well tolerated. The pivotal clinical trial for Patiromer FOS was conducted under a Special Protocol Assessment with the FDA.
About Relypsa, Inc.
Relypsa, Inc. is a 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 Oral Suspension, for the treatment of hyperkalemia, a potentially life-threatening condition defined as abnormally elevated levels of potassium in the blood, has been completed and the primary and secondary endpoints were met. A New Drug Application for Patiromer for Oral Suspension for the treatment of hyperkalemia was accepted by the U.S. Food and Drug Administration and is currently under review. Relypsa has global royalty-free commercialization rights to Patiromer for Oral Suspension, 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 statements regarding the potential approval of Patiromer for Oral Suspension, or Patiromer FOS, the robust clinical data for Patiromer FOS and the therapeutic and commercial potential of Patiromer FOS. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, 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 Relypsa's regulatory filings, Relypsa's substantial dependence on Patiromer FOS, Relypsa's commercialization plans and efforts and other matters that could affect the availability or commercial potential of Patiromer FOS. 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 Relypsa in general, see Relypsa's current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2014.
CONTACT: Alex Dobbin Associate Director, Investor Relations and Corporate Affairs 650.421.9687 IR@relypsa.com