Sub-group Analysis of AMETHYST-DN Trial Results Led by Bertram Pitt, M.D.
Sponsored Panel at ACC Led by Prominent Thought Leader, Dr. Ileana L. Piña, will Review the Latest Data in Management of Hyperkalemia
REDWOOD CITY, Calif., March 14, 2015 (GLOBE NEWSWIRE) -- Relypsa Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced that one year data showing the safety and efficacy of Patiromer for Oral Suspension (Patiromer FOS), Relypsa's lead product candidate, in heart failure (HF) patients with hyperkalemia receiving ongoing treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors will be presented today as a poster at the American College of Cardiology 64th Annual Scientific Session. The poster data is a sub-group analysis of a multi-center, randomized, open-label Phase 2 trial, AMETHYST-DN, led by Bertram Pitt, M.D., Professor of Medicine, Emeritus, University of Michigan School of Medicine. In addition, Relypsa is sponsoring an industry panel to review the latest data in the management of hyperkalemia, led by Ileana L. Piña, MD, Professor of Medicine and Epidemiology & Population Health at Albert Einstein College of Medicine.
The U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) action date of October 21, 2015 for completion of the review of the New Drug Application (NDA) for Patiromer FOS.
"Hyperkalemia is a serious condition that is common amongst patients with heart failure and chronic kidney disease, especially those undergoing renin-angiotensin-aldosterone-system inhibitor (RAASi) therapy," said Lance Berman, M.D., chief medical officer of Relypsa. "These results from this long-term study demonstrate that Patiromer FOS is able to control hyperkalemia in the chronic setting, while simultaneously allowing HF patients to continue to receive necessary treatment for their underlying disease."
The data showed that Patiromer FOS was well tolerated and corrected hyperkalemia in these patients and maintained normal potassium levels for up to one year. A total of 105 patients diagnosed with HF, chronic kidney disease, type 2 diabetes and mild or moderate hyperkalemia on RAASi therapy were studied over 52 weeks. Statistically significant reductions in mean serum potassium were observed at Day 3 (approximately 48 hours after the first dose of Patiromer FOS) in HF patients with both mild and moderate hyperkalemia, from baseline means of 5.1±0.03 and 5.6±0.09 mEq/L, respectively. Mean serum potassium was within normal levels (3.8 to 5.0 mEq/L) at Day 3 and week one and was maintained for 52 weeks. These results were consistent with the 199 non-HF patients participating in the trial. In HF and non-HF patients, after discontinuation of Patiromer FOS, serum potassium levels rapidly increased. Patiromer FOS was well tolerated with low rates of hypokalemia and discontinuations due to adverse events, regardless of HF diagnosis.
Details of the Patiromer FOS poster and industry panel are as follows:
Poster Presentation
Saturday, March 14: 3:45 to 4:30 PM PT
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1-Year Safety and Efficacy of Patiromer for Hyperkalemia in Heart Failure Patients with Chronic Kidney Disease on Renin-Angiotensin-Aldosterone System Inhibitor
(Pitt et al; Poster #1145-184)
Industry Theatre Session
Saturday, March 14: 3:45 to 4:45 PM PT
About Hyperkalemia
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, 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.