Ardelyx Showcased Encouraging Data on Treatment Satisfaction and Efficacy of IBSRELA® (tenapanor) for IBS-C at GHAPP 2023
11 September 2023 - 2:00PM
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded
with a mission to discover, develop and commercialize innovative,
first-in-class medicines that meet significant unmet medical needs,
shared encouraging data on IBSRELA® (tenapanor) via two poster
presentations presented at the 2023 Gastroenterology &
Hepatology Advanced Practice Providers (GHAPP) Annual Conference
currently being held in National Harbor, Maryland September 7-9.
IBSRELA, discovered and developed by Ardelyx, is a first-in-class
treatment with a novel mechanism that is approved by the U.S.
Food and Drug Administration to treat irritable bowel syndrome
with constipation (IBS-C) in adults.
“IBS-C can be incredibly challenging to manage and can
significantly disrupt the quality of life for many patients who
experience multiple symptoms, including abdominal pain, bloating
and discomfort. There is a growing body of data that continues to
expand our understanding of IBSRELA and how it works to provide
symptomatic relief. These data provide additional evidence of
IBSRELA’s safety and efficacy, bringing much needed relief to those
living with IBS-C,” said Laura Williams, MD, MPH, chief medical
officer of Ardelyx. “The data presented at GHAPP demonstrate that
people with IBS-C are experiencing significant improvements in
abdominal symptom scores when treated with IBSRELA and that
efficacy and durability are consistent across a diverse group of
patients. These symptomatic improvements are also manifested in
patient reported outcomes of treatment satisfaction.”
The first poster presented, Analysis of Patient-Reported
Treatment Satisfaction and Abdominal Score in Patients with
Irritable Bowel Syndrome with Constipation (IBS-C) Treated with
Tenapanor, which was previously presented at the 2023
Digestive Disease Week Conference, reported results from a post hoc
analysis of the T3MPO-2 trial of IBSRELA in adult patients with
IBS-C to examine the relationship between patient-reported
satisfaction (as measured by adequate relief and degree of relief)
and improvement in abdominal symptoms. The Phase 3 T3MPO-2 trial
randomized patients to tenapanor 50 mg twice a day or matched
placebo for 26 weeks of treatment. This post hoc analysis found
that IBSRELA-treated patients with IBS-C reported a reduction in
abdominal symptom scores compared to placebo. The analysis also
indicates that patient-reported treatment satisfaction was strongly
correlated with the IBS-C abdominal score (AS3, combining mean
weekly abdominal pain, bloating and discomfort scores) and could be
a useful tool to assess clinically meaningful improvements in adult
patients with IBS-C.The second poster presented at GHAPP, A
Subgroup Efficacy Analysis in Patients with IBS-C from the
Tenapanor Phase 3 Studies, reported results from a pooled
analysis from the T3MPO-1 and T3MPO-2 trials of IBRSELA in adult
patients with IBS-C which evaluated patients based on baseline
characteristics including abdominal pain severity, sex, age and
race to better understand efficacy across these subgroups. Patients
were randomized to tenapanor 50 mg twice per day or placebo for 12
weeks in T3MPO-1 and for 26 weeks in T3MPO-2. The post hoc pooled
analysis found that a higher proportion of patients randomized to
tenapanor versus placebo had a durable complete spontaneous bowel
movement (CSBM) response. Additionally, for most subgroups, a
higher proportion of patients randomized to tenapanor versus a
placebo had an early CSBM and spontaneous bowel movement (SBM)
response. The analysis also indicated that the results were not
affected by a variety of patient characteristics, including age,
race, sex and those with differing baseline abdominal pain severity
scores.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC
PATIENTS |
IBSRELA is contraindicated in patients less than 6 years of age; in
nonclinical studies in young juvenile rats administration of
tenapanor caused deaths presumed to be due to dehydration. Avoid
use of IBSRELA in patients 6 years to less than 12 years of age.
The safety and effectiveness of IBSRELA have not been established
in patients less than 18 years of age. |
CONTRAINDICATIONS
- IBSRELA is contraindicated in patients less than 6 years of age
due to the risk of serious dehydration.
- IBSRELA is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
WARNINGS AND PRECAUTIONSRisk of Serious
Dehydration in Pediatric Patients
- IBSRELA is contraindicated in patients below 6 years of age.
The safety and effectiveness of IBSRELA in patients less than 18
years of age have not been established. In young juvenile rats
(less than 1 week old; approximate human age equivalent of less
than 2 years of age), decreased body weight and deaths occurred,
presumed to be due to dehydration, following oral administration of
tenapanor. There are no data available in older juvenile rats
(human age equivalent 2 years to less than 12 years).
- Avoid the use of IBSRELA in patients 6 years to less than 12
years of age. Although there are no data in older juvenile rats,
given the deaths in younger rats and the lack of clinical safety
and efficacy data in pediatric patients, avoid the use of IBSRELA
in patients 6 years to less than 12 years of age.
Diarrhea Diarrhea was the most common adverse
reaction in two randomized, double-blind, placebo-controlled trials
of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated
patients. If severe diarrhea occurs, suspend dosing and rehydrate
patient.
MOST COMMON ADVERSE REACTIONS The most common
adverse reactions in IBSRELA-treated patients (incidence ≥2% and
greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal
distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2%
vs <1%).
INDICATION IBSRELA (tenapanor) is indicated for
the treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
in adults.
Please see full Prescribing
Information, including Boxed Warning, for
additional risk information.
About Irritable Bowel Syndrome with Constipation
(IBS-C)Irritable bowel syndrome with constipation (IBS-C)
is a gastrointestinal disorder characterized by both abdominal pain
and altered bowel movements, estimated to affect 12 million people
in the U.S. IBS-C is associated with significantly impaired quality
of life, reduced productivity, and substantial economic burden.
About IBSRELA for IBS-CIBSRELA (tenapanor) is a
locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3),
an antiporter expressed on the apical surface of the small
intestine and colon primarily responsible for the absorption of
dietary sodium. By inhibiting NHE3 on the apical surface of the
enterocytes, tenapanor reduces absorption of sodium from the small
intestine and colon, thus retaining luminal water content, which
accelerates intestinal transit time and results in a softer stool
consistency. IBSRELA has also been shown to reduce abdominal pain
by decreasing visceral hypersensitivity and by decreasing
intestinal permeability in animal models. In a rat model of colonic
hypersensitivity, tenapanor reduced visceral hyperalgesia and
normalized colonic sensory neuronal excitability.
About Ardelyx, Inc.Ardelyx was founded with a
mission to discover, develop and commercialize innovative,
first-in-class medicines that meet significant unmet medical needs.
Ardelyx’s first approved product, IBSRELA® (tenapanor) is available
in the United States and Canada. Ardelyx is developing XPHOZAH®
(tenapanor), a novel product candidate for the control of serum
phosphate in adult patients with chronic kidney disease (CKD) on
dialysis who have had an inadequate response or intolerance to
phosphate binder therapy, which has completed three successful
Phase 3 trials and an additional two Phase 4 open label trials.
Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the
potential treatment of elevated serum potassium, or hyperkalemia, a
problem among certain patients with kidney and/or heart disease and
an early-stage program in metabolic acidosis, a serious electrolyte
disorder in patients with CKD. Ardelyx has established agreements
with Kyowa Kirin in Japan, Fosun Pharma in China and Knight
Therapeutics in Canada for the development and commercialization of
tenapanor in their respective territories. For more information,
please visit https://ardelyx.com/ and connect with us on X
(formerly Twitter), LinkedIn and Facebook.
Investor and Media Contacts: Caitlin
Lowieclowie@ardelyx.com
Kimia Keshtbod kkeshtbod@ardelyx.com
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