Vifor Pharma’s Phase-II AMBER Study Meets Primary Endpoint

May 10, 2019 Off By BusinessWire

- Veltassa^® (patiromer) enables spironolactone for blood
  pressure management in patients with resistant hypertension and
  chronic kidney disease by controlling blood potassium levels.

ZURICH–(BUSINESS WIRE)–Regulatory News:

Vifor Pharma today announced results from the phase-II AMBER study which
demonstrated that a significantly higher proportion of patients with
resistant hypertension (RHTN) and chronic kidney disease (CKD) taking
Veltassa^® (patiromer) remained on spironolactone therapy
compared to patients taking placebo at week 12. Veltassa^®was
shown to enable persistent use of spironolactone by controlling blood
potassium levels. The data were presented at the 2019 National Kidney
Foundation (NKF) Congress in Boston, MA on 10 May 2019.

The study achieved statistical significance of its pre-specified primary
endpoint by demonstrating that a significantly higher proportion of
patients taking Veltassa^® remained on spironolactone therapy
through 12 weeks of treatment versus placebo with concomitant
spironolactone in patients with RHTN and CKD (86% vs. 66%, p < .0001,
respectively). Safety results are consistent with existing Veltassa^®data, with no new safety issues identified.

“Despite the efficacy of spironolactone in patients with RHTN, its use
has never been studied in those who also have CKD due to the occurrence
or risk of developing hyperkalaemia,” said Dr. Rajiv Agarwal, Professor
of Medicine, Indiana University School of Medicine. “The AMBER data
suggest that patients treated with patiromer may be more likely to stay
on spironolactone therapy, a life-saving medicine for those with RHTN.”

Spironolactone, a renin-angiotensin aldosterone system inhibitor
(RAASi), is a key component in the recommended treatment guidelines for
patients with resistant hypertension^1,2. However, it is
challenging for many patients to stay on spironolactone treatment
because it can further increase the risk of hyperkalaemia (elevated
blood potassium levels), a condition that can cause abnormal heart
rhythms and even sudden death³.

“We are pleased with the AMBER study results and hope these data will
support better adherence to guideline-directed treatment for patients
with resistant hypertension and chronic kidney disease,” said Thierry
Teil, Chief Medical Officer of Vifor Pharma. “We look forward to
partnering with the community to further validate and explore the
promise of Veltassa^® in fulfilling a clear unmet need among a
complex patient population.”

AMBER is A RandoMized, Double-Blind,
Placebo-controlled, Parallel Group Study of Patiromer for the Enablement
of Spironolactone Use for Blood PrEssure Control in
Patients with Resistant Hypertension and Chronic Kidney Disease:
Evaluation of Safety and Efficacy. Approximately 290 patients at 60
sites in the United States, South Africa, the United Kingdom, France,
Germany, Croatia, Hungary, Georgia, and Ukraine were enrolled in the
study. The primary endpoint was the percentage of subjects remaining on
spironolactone at week 12 compared between treatment groups
(spironolactone and patiromer versus spironolactone and placebo).

About Hyperkalaemia
Approximately 73 percent of advanced CKD
and 40 percent of chronic heart failure (HF) patients may be at risk of
elevated blood potassium levels⁴. Hyperkalaemia 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 often prescribed to people with CKD and HF to help
delay progression of their underlying disease and reduce mortality can
cause hyperkalaemia as a side effect. These may include RAASi such as
angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and
angiotensin-converting-enzyme (ACE) inhibitors as well as angiotensin II
receptor/neprilysin inhibitors (ARNI).

About Veltassa^®
Veltassa^® is a
sodium-free potassium binder approved for the treatment of
hyperkalaemia. Veltassa^® should not replace emergency
treatment for life-threatening hyperkalaemia. Made in powder form
consisting of smooth, spherical beads, Veltassa^® is mixed
with water 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 about Veltassa^® in the
United States

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) are 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 Veltassa^®’s full Prescribing Information, please visit https://www.veltassa.com/pi.pdf.

Vifor Pharma Group is a global pharmaceuticals company
headquartered in Switzerland. It aims to become the global leader in
iron deficiency, nephrology and cardio-renal therapies. The company is
the partner of choice for pharmaceuticals and innovative patient-focused
solutions. Vifor Pharma Group strives to help patients around the world
with severe and chronic diseases lead better, healthier lives. The
company develops, manufactures and markets pharmaceutical products for
precision patient care. Vifor Pharma Group holds a leading position in
all its core business activities and consists of the following
companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a
joint company with Fresenius Medical Care); Relypsa; and OM Pharma.
Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss
Exchange, VIFN, ISIN: CH0364749348). For more information, please visit www.viforpharma.com.

Relypsa, Inc., a Vifor Pharma Group company, is a
biopharmaceutical company focused on the development and
commercialisation of late-stage medicines in the iron deficiency,
nephrology and cardio-renal therapeutic areas. Relypsa is committed to
delivering innovative therapies and improving the lives of patients with
serious and life-threatening conditions that are often overlooked and
undertreated. The company’s first medicine, Veltassa^®
(patiromer) for oral suspension, was approved by the U.S. FDA in October
2015, making it the first approved medicine for the treatment of
hyperkalaemia in more than 50 years. More information is available at www.relypsa.com.

References
¹ Yancy C et al. American Heart
Association. Guideline for the Management of Heart Failure. August 2017.
Accessible via http://www.ksw-gtg.com/hfguidelines/pdfs/HFTreatmentHypertensionHFrEF.pdf.
²
Ponikowski P et al. 2016 ESC Guidelines for the diagnosis and treatment
of acute and chronic heart failure: The Task Force for the diagnosis and
treatment of acute and chronic heart failure of the European Society of
Cardiology (ESC). Eur Heart J. 2016;37:2129-2200.
³Rastegar
A, Soleimani M. Hypokalaemia and hyperkalaemia. Postgrad Med J.
2001;77:759-764.
⁴ Rosano GCM, et al. Expert consensus
document on the management of hyperkalaemia in patients with
cardiovascular disease treated with renin angiotensin aldosterone system
inhibitors: coordinated by the Working Group on Cardiovascular
Pharmacotherapy of the European Society of Cardiology.Eur Heart J
2018;4:180-188.