News | September 15, 2014
Relypsa Announces New Analysis of Phase 3 Data Demonstrating Patiromer’s Ability to Rapidly Correct, and Prevent Recurrence of, Hyperkalemia in Heart Failure and Non-Heart Failure Patients
REDWOOD CITY, Calif., Sept. 15, 2014 (GLOBE NEWSWIRE) — Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced that data in heart failure (HF) patients from its pivotal Phase 3 clinical trial of patiromer, the company’s lead product candidate, were presented as a late-breaking oral presentation at the 18th Annual Scientific Meeting for the Heart Failure Society of America (HFSA) being held in Las Vegas. Consistent with the results from the overall population, patiromer rapidly corrected hyperkalemia and prevented recurrence of this serious condition in heart failure as well as non-heart failure patients. In addition, the data showed that fewer patients treated with patiromer discontinued guideline recommended renin-angiotensin-aldosterone-system inhibitor (RAASi) therapy compared to placebo.
“The data from this study provide additional evidence that patiromer normalizes high serum potassium levels in HF patients, a vulnerable group of patients at risk for hyperkalemia,” said Lance Berman, M.D., chief medical officer of Relypsa. “In addition, the results demonstrated that continued treatment with patiromer reduced the risk of recurrent hyperkalemia which is an important potential benefit since these patients also had chronic kidney disease and were receiving RAASi medication.”
“Unfortunately, RAAS inhibitor use is limited due to the risk of hyperkalemia,” said Bertram Pitt, M.D., professor of Medicine, Emeritus, University of Michigan School of Medicine. “The ability of patiromer to treat hyperkalemia and prevent its recurrence in patients with heart failure, as well as to potentially increase the proportion of patients who remain on guideline-recommended RAASi inhibitors, may have important implications for the management of patients with heart failure.”
The data, which were generated as part of Relypsa’s Phase 3 program for patiromer, were presented at HFSA by Dr. Pitt. The two-part Phase 3 clinical trial was conducted under special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA). Part A, in which all participants received patiromer, was a single-blind trial in 243 patients with hyperkalemia (102 HF, 141 non-HF) who were also being treated with RAAS inhibitor medications. The primary endpoint of Part A was the change in serum potassium from Part A baseline to Part A week 4. Part B, the placebo controlled randomized withdrawal phase of the trial, was designed to provide additional evidence of the efficacy of patiromer in treating hyperkalemia and to assess the need for chronic dosing. Patients from Part A whose baseline serum potassium level was greater than or equal to 5.5 mEq/L at enrollment and whose serum potassium level was controlled at week 4 were eligible for Part B. These patients were then randomized into two groups: one to continue on patiromer (27 HF, 28 non-HF), and a second to receive placebo (22 HF, 30 non-HF) instead of patiromer for an additional eight weeks. The primary endpoint for Part B was the difference between the patiromer and placebo groups in the change in serum potassium from Part B baseline to Part B week 4 or to an earlier time point when the patient first had serum potassium less than 3.8 mEq/L or greater than or equal to 5.5 mEq/L.
All Part A and Part B efficacy endpoints for patients with and without HF were met. For the Part A primary endpoint, a statistically significant reduction in serum potassium of 1.06 mEq/L (p < 0.001) was demonstrated in patients with HF which was similar to the reduction demonstrated for those without HF. For the Part B primary endpoint, the difference between the placebo and the patiromer groups in the median change from Part B baseline in serum potassium in patients with HF was 0.64 mEq/L(95% CI, 0.29, 0.99), p < 0.001; which was also similar to that demonstrated in patients without HF. In addition, fewer heart failure patients in the patiromer group experienced recurrent hyperkalemia than the placebo group (8 percent compared to 52 percent, p < 0.001) with a similar trend in non-heart failure patients (23 percent compared to 66 percent, p < 0.001). Consequently, more patiromer-treated patients remained on guideline-recommended RAASi therapy compared to placebo. Patiromer was well tolerated in both HF and non-HF patients with a low risk of hypokalemia.
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 correct, and prevent the recurrence of, hyperkalemia and increase the proportion of patients who remain on guideline-recommended RAAS inhibitor therapy, and the potential benefits and implications of these findings. 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, its commercialization plans and efforts and other matters that could affect the availability 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 the company’s current and future reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2014.
VP, Investor Relations & Corporate Affairs