Relypsa, Inc. Announces Phase 3 Patiromer Data To Be Presented In Late-Breaking Session At Heart Failure Society Of America 18th Annual Scientific Meeting
REDWOOD CITY, Calif., Sept. 8, 2014 (GLOBE NEWSWIRE) -- Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced that data from its pivotal Phase 3 clinical trial of patiromer, the company's lead product candidate, will be presented as a late-breaking oral presentation at the 18th Annual Scientific Meeting for the Heart Failure Society of America (HFSA) to be held in Las Vegas during September 14-17, 2014.
The data will be presented at HFSA by Bertram Pitt, M.D., professor of Medicine, Emeritus, University of Michigan School of Medicine. An analysis of the data will be presented that assesses the ability of patiromer to reduce elevated serum potassium (serum K+). Following the achievement of normal potassium levels, the study then evaluated whether continued treatment with patiromer would maintain control of serum K+ and reduce the recurrence of hyperkalemia compared to placebo. The analysis was conducted in heart failure (HF) patients with chronic kidney disease (CKD) and mild to severe hyperkalemia who were also receiving renin angiotensin aldosterone system (RAAS) inhibitor therapy.
In addition to presenting placebo-controlled comparative data on the recurrence of hyperkalemia after having controlled serum potassium levels, the presentation will include findings on whether HF patients in the study were able to remain on guideline-recommended RAAS inhibitor therapy.
Details of the presentation are as follows:
| Title: | Serum Potassium Reduction and Prevention of Recurrent Hyperkalemia with Patiromer in Patients with Heart Failure and Chronic Kidney Disease on RAAS Inhibitors |
| Presenter: | Bertram Pitt, M.D., Professor of Medicine, Emeritus, Univ. of Michigan School of Medicine, Ann Arbor, MI |
| Session: | Late Breaking Clinical Trials |
| Date: | Monday, September 15, 2014 |
| Time: | 3:30 – 5:00 p.m. PT |
About Hyperkalemia and Patiromer
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.
Patiromer (RLY5016 for Oral Suspension) is a high capacity non-absorbed, non-metal 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 study, a 12-month Phase 2 trial and a 48-hour short-term Phase 1 onset-of-action study. In all of those studies, patiromer met its efficacy endpoints and the treatment was well tolerated. The pivotal clinical study for patiromer is complete and 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 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. 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 statements regarding the potential ability of patiromer to reduce, and maintain control of, serum K+ and reduce the recurrence of hyperkalemia compared to placebo and the potential of HF patients in the study to remain on guideline-recommended RAAS inhibitor therapy. Such forward-looking statements involve substantial risks and uncertainties that relate to future events and the actual results could 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 the company's regulatory filings, the company's substantial dependence on patiromer, the company's commercialization plans and efforts and other matters that could affect the availabi lity or commercial potential of patiromer . 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 current and future reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2014.
CONTACT: Sylvia Wheeler VP, Investor Relations & Corporate Affairs 650-421-9504 IR@relypsa.com 