Relypsa, Inc. Reports Positive Top-Line Results for the Second Part of Its Two-Part Pivotal Phase 3 Trial of Patiromer
10/10/2013 7:07:06 AM
Relypsa Reports Positive Top-Line Results for the Second Part of Its Two-Part Pivotal Phase 3 Trial of Patiromer
REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Relypsa, Inc., a clinical-stage biopharmaceutical company, today announced positive results on both the primary and secondary efficacy endpoints of Part B, the placebo controlled randomized withdrawal part of its two-part pivotal Phase 3 clinical trial evaluating patiromer for the treatment of hyperkalemia. The results demonstrate that, after having treated hyperkalemia and controlled serum potassium in the treatment phase (Part A) of the trial, hyperkalemia recurred at any time during Part B in significantly more subjects randomized to placebo than in subjects who continued to receive patiromer, supporting chronic dosing in order to maintain serum potassium levels in the normal range. Taken together with the positive results from the previously reported Part A data, the Part B data indicate that patiromer is an effective treatment for hyperkalemia.
The topline Part B results were both statistically significant and clinically meaningful:
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 was 0.72 mEq/L (95% CI 0.46, 0.97), p
The two secondary endpoints evaluated the proportion of subjects in each group who developed recurrent hyperkalemia (defined as having a serum potassium = 5.1 mEq/L and = 5.5 mEq/L) after having been controlled on patiromer in Part A:
More placebo subjects (91%) developed recurrent hyperkalemia with a serum potassium = 5.1 mEq/L at any time during Part B than patiromer subjects (43%). This difference between groups of 48% (95% CI, 0.33, 0.63) was statistically significant, p
More placebo subjects (60%) developed recurrent hyperkalemia with a serum potassium = 5.5 mEq/L at any time during Part B than patiromer subjects (15%). This difference between groups of 45% (95% CI, 0.29, 0.61) also was statistically significant, p
The two-part Phase 3 clinical trial was conducted under an agreed upon 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, single-arm trial in 243 subjects with hyperkalemia and chronic kidney disease (CKD) who were also being treated with renin angiotensin aldosterone system (RAAS) inhibitor medications. Part A met both the primary and secondary efficacy endpoints, with results that were both statistically significant and clinically meaningful.
Part B was designed to provide additional evidence that chronic administration with patiromer maintains control of serum potassium levels and that once patiromer treatment is withdrawn, hyperkalemia recurs. Subjects from Part A whose baseline serum potassium level was at least 5.5 mEq/L at enrollment and whose serum potassium level was controlled at week 4 were eligible for Part B. These subjects were then randomized into two groups: one to continue on patiromer and the second to receive placebo for an additional eight weeks.
According to President and Chief Executive Officer John Orwin, “The strength of the data from both Parts A and B underscore the effectiveness of patiromer and, importantly, point to the benefit of long-term, chronic dosing with patiromer. Given the limited treatment options for patients with hyperkalemia, in particular those with chronic kidney disease or heart failure who are taking RAAS inhibitor medications, these Phase 3 data further highlight the opportunity ahead for Relypsa and its lead product candidate, patiromer. We plan to seek US regulatory approval for the treatment of hyperkalemia in order to commercialize patiromer and bring this important medication to patients.”
The Company also said today that it expects to report within the next few weeks results from its 52-week phase 2b clinical trial, known as AMETHYST-DN, which evaluated the safety and efficacy of patiromer in reducing hyperkalemia in 306 patients with CKD who were being treated with RAAS inhibitors.
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. Relypsa has completed several clinical trials of patiromer that have demonstrated the efficacy, safety and tolerability of patiromer in patients with hyperkalemia.
About Special Protocol Assessments
A Special Protocol Assessment is a written agreement between a sponsor and the FDA that the design and planned analysis of a clinical trial can adequately address objectives in support of a marketing application. Final determinations for marketing approval are made after a complete review of a marketing application. Approval is based on the entire data in the application. For further information regarding the SPA process, please visit the FDA website, www.fda.gov.
About Relypsa, Inc.
Relypsa, Inc. is a privately held 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.
Shari Annes, 650-888-0902 (Cell)
IR and Corporate Communications
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