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Data from New Analyses of Studies with Veltassa® Presented at National Kidney Foundation 2016 Spring Clinical Meetings

REDWOOD CITY, Calif., April 28, 2016 (GLOBE NEWSWIRE) -- Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced data from new analyses of studies with Veltassa® (patiromer) for oral suspension were presented at the National Kidney Foundation (NKF) 2016 Spring Clinical Meetings in Boston.

“The data presented today demonstrated that the calcium available to be absorbed from Veltassa is limited and that some of the calcium released during exchange for potassium may bind phosphate, which could be important for certain patients with chronic kidney disease,” said Lance Berman, M.D., chief medical officer of Relypsa. “Another analysis showed patients with resistant hypertension taking Veltassa in the AMETHYST-DN study had decreases in blood pressure, which is a finding we are interested in exploring further.”

Effect of Veltassa on Urine Calcium and Phosphate Excretion in Healthy Adults (Poster #309)
Presented by David A. Bushinsky, M.D., John J. Kuiper Distinguished Professor of Medicine and of Pharmacology and Physiology at the University of Rochester School of Medicine, and chief of the Nephrology Division at the University of Rochester Medical Center

This analysis of the Phase 1 RLY5016-101 and RLY5016-102 studies examined the change in urine excretion of calcium, phosphate and potassium in 32 healthy volunteers treated with Veltassa.

Results showed that:

  • Daily administration of Veltassa at the highest approved dose (25.2 grams daily) resulted in a decrease in urine potassium (29.2±8.1 mEq/d), only a small increase in urine calcium (approximately 73 mg/d) and a parallel decrease in urine phosphate (approximately 64 mg/d).
  • Mean blood calcium and phosphate values were within the normal range and remained stable throughout treatment.
  • The most common adverse events were gastrointestinal events that were mild or moderate in severity. No serious adverse events were reported, and no study participants discontinued treatment because of an adverse event.

Effect of Veltassa on Potassium and Phosphate in Patients on Hemodialysis (Poster #310)
Presented by Dr. Bushinsky

In a proof of concept study (RLY5016-201), six hyperkalemic hemodialysis patients were admitted to a clinical research center, discontinued their phosphate binders and placed on a controlled diet. During the two week in-unit study, patients’ blood potassium and phosphate levels were measured daily.

Results of this small study found:

  • During the pretreatment week, 69.0 percent, 47.6 percent and 11.9 percent of patients’ daily blood potassium values were ≥5.5, ≥6.0 and ≥6.5 mEq/L, respectively.
  • With Veltassa treatment, these proportions were reduced to 38.1 percent (p=0.008), 11.9 percent (p<0.001) and 2.4 percent, respectively (p=0.2).
  • During the pretreatment week, following discontinuation of phosphate binders, patients’ blood phosphate levels increased numerically from 5.8±0.4 to 7.0±0.5 mg/dL (p=0.06) over the long interdialytic period (the two-day interval between dialysis sessions that occurs over weekends).
  • During the Veltassa treatment week, blood phosphate levels decreased from 7.0±0.5 to 6.2±0.5 mg/dL (p=0.04) over the long interdialytic period.
  • No serious adverse events were reported, and none of the patients discontinued treatment because of an adverse event. No patients experienced hypokalemia.

AMETHYST-DN Post-Hoc Analysis of Patients with Resistant Hypertension with Diabetic Kidney Disease (Poster #313)
Presented by Murray Epstein, M.D., professor of medicine at the Leonard M. Miller School of Medicine at the University of Miami

This post-hoc analysis of the AMETHYST-DN study1 assessed the effect of Veltassa on blood potassium levels and blood pressure in a sub-group of patients with diabetic kidney disease and resistant hypertension.

Of the 304 patients in AMETHYST-DN, which evaluated Veltassa over 52 weeks in hyperkalemic patients with chronic kidney disease (CKD) and type 2 diabetes who were taking renin angiotensin aldosterone system (RAAS) inhibitors, 79 had resistant hypertension and 50 of those completed the study.

In the sub-group of patients with resistant hypertension, results showed:

  • Veltassa significantly reduced blood potassium levels.
  • In those with mild or moderate hyperkalemia, mean blood potassium decreased significantly from baseline to day 3, the first post-baseline visit (p<0.001 for both groups).
  • Target potassium levels (3.8–<5.0 mEq/L) were achieved at day 3 for those with mild hyperkalemia and at week 1 for those with moderate hyperkalemia, and were maintained through week 52.
  • Mean blood pressure across both groups decreased by −18.4 (systolic) and −10.1 mm Hg (diastolic) from baseline to the week 52 visit. Similar blood pressure reduction was observed in patients without resistant hypertension.
  • Veltassa was generally well tolerated in patients with resistant hypertension, and the rate of discontinuations due to adverse events was low (12.7 percent) over 52 weeks. Constipation (10.1 percent, none severe) and hypomagnesemia (8.9 percent, none severe) were the two most common treatment-related adverse events.

About Hyperkalemia
Approximately 3 million people in the United States with stage 3 or 4 CKD and/or heart failure have hyperkalemia, or elevated blood potassium levels. Hyperkalemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are frequently prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalemia as a side effect. These include RAAS inhibitors, such as ARBs (angiotensin receptor blockers), AAs (aldosterone antagonists) and ACE (angiotensin-converting-enzyme) inhibitors.

About Veltassa
Veltassa was approved by the U.S. Food and Drug Administration for the treatment of hyperkalemia in the United States on October 21, 2015, becoming the first medicine in more than 50 years for people with elevated serum potassium.

Veltassa is a potassium binder approved for the treatment of hyperkalemia. Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

Made in powder form consisting of smooth, spherical beads, Veltassa is mixed with water (90 milliliters or 3 ounces) and taken once-a-day with food. Veltassa is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.

IMPORTANT SAFETY INFORMATION

The Prescribing Information for Veltassa includes a Boxed Warning that Veltassa binds to many other orally administered medications, which could decrease their absorption and reduce their effectiveness. Other oral medications should be administered at least 6 hours before or 6 hours after Veltassa. Doctors should choose Veltassa or the other oral medication if adequate dosing separation is not possible.

Contraindications
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components.

Worsening of Gastrointestinal Motility
Use of Veltassa should be avoided in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.

Hypomagnesemia
Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3 percent of patients treated with Veltassa. Approximately 9 percent of patients in clinical trials developed hypomagnesemia with a serum magnesium value <1.4 mg/dL. Doctors should monitor serum magnesium and consider magnesium supplementation in patients who develop low serum magnesium levels.

Adverse Reactions
The most common adverse reactions (incidence ≥2 percent) were constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa and included edema of the lips.

For additional Important Safety Information and Veltassa’s full Prescribing Information, please visit www.relypsa.com/veltassa/prescribing-information.

About Relypsa, Inc.
Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company’s first medicine, Veltassa (patiromer) for oral suspension, was developed based on Relypsa’s rich legacy in polymer science. Veltassa is approved in the United States for the treatment of hyperkalemia. Veltassa has intellectual property protection until 2030 in the United States and 2029 in the European Union. 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 importance of the data presented today for certain patients with chronic kidney disease and the potential interest in exploring the findings of the analysis showing patients with resistant hypertension taking Veltassa in the AMETHYST-DN study had decreases in blood pressure. 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 and commercialization process, including regulatory requirements, Relypsa's substantial dependence on Veltassa, Relypsa's commercialization plans and efforts and other matters that could affect the availability or commercial potential of Veltassa. 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, 2015.

1 Bakris GL, Pitt B, Weir MR, Freeman MW, Mayo MR, et al. Effect of patiromer on serum potassium level in patients with hyperkalemia and diabetic kidney disease. The AMETHYST-DN Randomized Clinical Trial. JAMA, 2015;314(2):151-161.

Contact:
Alex Dobbin
Associate Director, Investor Relations
650.421.9352
IR@relypsa.com

Source:Relypsa, Inc.