REDWOOD CITY, Calif., Jan. 13, 2014 (GLOBE NEWSWIRE) -- Relypsa, Inc. (Nasdaq:RLYP), a clinical-stage biopharmaceutical company, today provided a corporate update including new data on the modification of renin-angiotensin-aldosterone system inhibiting (RAASi) therapies from Part B of its two-part Phase 3 trial evaluating patiromer as a treatment for hyperkalemia; a new agreement with Lanxess to ensure the commercial manufacture and supply of the active ingredient of patiromer; and an update with respect to its senior management team. In addition, Relypsa confirmed that it is on track to submit a new drug application (NDA) for patiromer to the U.S. Food and Drug Administration (FDA) in the third quarter of this year, and expects to complete an approximately 20-patient Phase 1 onset-of-action study in the first half of this year.
New RAASi data from Pivotal Phase 3 Study
Relypsa commented today on results from the pre-defined exploratory endpoints from its two-part pivotal Phase 3 clinical trial evaluating patiromer for the treatment of hyperkalemia, which was conducted under an agreed upon special protocol assessment (SPA) with the FDA. The exploratory endpoints consisted of (1) the proportion of subjects requiring any dose modification of RAASi therapies (i.e. down titration or discontinuation) because of hyperkalemia at any time during the Part B 8-week period and (2) the proportion of subjects receiving any dose of a RAASi medication at the end of Part B. After achieving normalized serum potassium levels with patiromer treatment in Part A, subjects entered the Part B withdrawal phase and were randomized to either continue treatment with patiromer or receive placebo. If recurrent hyperkalemia developed during Part B, RAASi therapy dose reduction occurred in the placebo group and patiromer up titration occurred in the patiromer group. In either group, if these interventions did not normalize serum potassium, discontinuation of RAASi medication was required in order to control rising potassium levels.
The pivotal Phase 3 clinical trial data show that as a result of recurrent hyperkalemia, significantly more placebo patients required dose modification of their RAASi therapies (62%) than patiromer patients (6%), p < 0.001; with more patiromer patients (94%) still on RAASi medication at the end of the trial than placebo patients (48%), p < 0.001.
According to Dr. Lance Berman, Chief Medical Officer at Relypsa, "Both Heart Failure and Chronic Kidney Disease guidelines developed by expert clinicians, as well as the drug labels, advise dose reduction or discontinuation of the RAASi if a patient develops hyperkalemia. The additional findings from our pivotal Phase 3 trial suggest that by maintaining control of serum potassium with patiromer, more patients can remain on their guideline-recommended RAASi medication. This potential benefit could address the unmet need faced by nephrologists and cardiologists because for the first time, with patiromer, we may have a novel, well tolerated potassium-lowering therapy that can be used daily, over the long term, to treat chronic hyperkalemia and reduce the need to modify or stop RAASi therapies. "
Manufacturing and Supply Agreement
Relypsa also announced that it has entered into a multi-year manufacturing and supply agreement with Lanxess Corporation, a contract manufacturer of clinical material for the company's clinical trials and a subsidiary of the German-based specialty chemical group Lanxess. The agreement governs the manufacturing and supply for commercial sale of the active pharmaceutical ingredient (API) for patiromer as well as the support of Relypsa in preparing and filing its NDA. The operation will be executed by Lanxess' affiliate Saltigo, a leading supplier in the field of custom synthesis and contract manufacturing. Relypsa has already issued certain purchase orders for raw materials and API under a prior Memorandum of Understanding that will now be governed by the manufacturing and supply agreement, and going forward, Relypsa has agreed to purchase certain quantities of API.
Management Changes
Relypsa's Chief Executive Officer, John Orwin, announced that Mary Corbett has joined the company as Senior Vice President for Human Resources in December 2013. Corbett brings to Relypsa over 30 years of experience in human resources in a wide range of industries, including life sciences, technology, financial services and consumer goods. Previously, Corbett was Vice President for Human Resources at Verinata Health, a company acquired by Illumina, Inc., and prior to that, Corbett served as Vice President, Human Resources of Pacific Biosciences of California, Inc. During her tenure at Pacific Biosciences, the company grew from 150 to over 500 employees, launched its first product and completed an initial public offering. Corbett also previously headed the HR function for Synarc, Broadlane, myCFO, and MarketMile and had a consulting practice based in Paris for six years. She holds a BA from Fordham University and an MA from Columbia University.
At the same time, Orwin noted that Jerry Buysse, Senior Vice President and Chief Scientific Officer, has recently transitioned from a full-time position to a consultant for the Company. Dr. Buysse is one of several Relypsa founders, having led the team that discovered patiromer and advanced it from the laboratory to human clinical trials.
"Dr. Buysse will continue to provide expertise and guidance as we complete the preparation of our NDA submission and engage in conversations with the FDA about patiromer's potential approval and launch. Since the inception of Relypsa, his contributions have been significant, and we look forward to our new consulting relationship under which he intends to continue to work closely with us to see our common vision through to reality, while he also pursues new career opportunities," noted Orwin.
About Relypsa, Inc.
Relypsa, Inc. is a 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.
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 its expectations regarding (i) the timing of the submission of its NDA for patiromer, (ii) the timing of completion of its Phase 1 onset-of-action study, (iii) the potential of patiromer to reduce the need to modify or stop RAASi therapies and (iv) Dr. Buysse's contributions to the company as a consultant. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, 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 our regulatory filings, our substantial dependence on patiromer and other matters that could affect the availability or commercial potential of our drug candidate. 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 prospectus filed with the Securities and Exchange Commission on November 15, 2013, and its future periodic reports to be filed with the Securities and Exchange Commission.