Ardelyx Shares Positive Data on Symptom Response During Treatment With IBSRELA® (tenapanor) for IBS-C and hosts IBS-C Product Theater at ACG 2023
23 Octobre 2023 - 2:07PM
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,
announced that they will share positive data on IBSRELA®
(tenapanor) via an oral presentation and two posters at the
American College of Gastroenterology (ACG) annual meeting, being
held October 20 to 25 in Vancouver, Canada. IBSRELA, discovered and
developed by Ardelyx, is a first-in-class treatment that is
currently approved by the U.S. Food and Drug Administration to
treat irritable bowel syndrome with constipation (IBS-C) in adults.
“We are excited to share new data that adds to the robust body
of evidence supporting IBSRELA and its differentiated mechanism of
action, which is bringing much needed improvement to the lives of
people living with IBS-C,” said Laura Williams, MD, MPH, chief
medical officer of Ardelyx. “Physicians and other professionals
attending ACG 2023 work with IBS-C patients every day and know all
too well how challenging this condition can be. We are hopeful that
this data increases the enthusiasm we have already seen for this
new treatment and the potential it has to reduce the burden of
IBS-C symptoms.”
“The findings being presented today on the median time to first
response with IBSRELA are particularly meaningful for patients
seeking relief from the pain, bloating and discomfort associated
with IBS-C and demonstrate how important it is to give patients a
fair trial on IBSRELA,” added Brian E. Lacy, M.D., Ph.D., Professor
of Medicine, Mayo Clinic. “While a significant proportion of
patients will have an early positive response to IBSRELA treatment,
patient response rates increase with continued therapy. This
finding underscores the importance of maintaining treatment beyond
3-4 weeks, so as not to miss those patients who will improve with
time.”
- The oral presentation, titled Tenapanor Treatment
Success for IBS-C Symptoms Increases with Duration of
Therapy led by Dr. Brian E. Lacy, Dr. Yang Yang and Dr.
David P. Rosenbaum, will share findings from a pooled analysis of
the phase 2b and phase 3 T3MPO studies of IBSRELA in adult
patients. These studies looked at the effects of the drug on
abdominal pain and other IBS-C symptoms. The new post-hoc data
presented today evaluate the time to onset of tenapanor effect on
bowel function and abdominal symptoms in adult patients with IBS-C.
The researchers concluded that these patients experience a
relatively quick onset of symptom relief under tenapanor treatment
and that weekly response rates continued to increase with treatment
duration.
- The first poster to be presented at the ACG meeting, titled
Tenapanor Can Improve Abdominal Symptoms Independent of
Changes in Bowel Movement Frequency in Adult Patients with
IBS-C, also looks at data from the T3MPO studies to
examine effects on abdominal pain and abdominal score 3 (AS3),
independent of changes in bowel functions over the first 12 weeks
of the study. The data showed that tenapanor improved abdominal
symptoms regardless of improvement in complete solid bowel
movements (CSBMs) in adult patients with IBS-C and that improvement
in abdominal symptoms without improvement in CSBMs may be a result
of tenapanor’s novel mechanism of action that has been shown to
reduce both intestinal permeability and visceral hypersensitivity
in nonclinical studies.
- The second poster, Improvement in Bloating and Overall
Complete Spontaneous Bowel Movement Response with Tenapanor
Treatment: A Post Hoc Analysis of the IBS-C Clinical
Studies, analyzes data from the T3MPO studies to assess
the relationship between improvement in bloating and overall CSBM
response in patients treated with tenapanor. This analysis
concluded that patients with tenapanor demonstrated a marked
improvement in average weekly bloating score, and that patients who
had an overall CSBM response had a greater improvement in bloating
than those who did not.
These poster presentations are publicly available and can be
accessed on demand here.
In addition to the poster presentations during
ACG, Ardelyx is sponsoring a Product
Theater titled Discover a Different Mechanism of
Action to Treat Adults With IBS-C: A Case Based Discussion
on Monday, October 23, 2023, from 2:30 to 3:00 PM PT at booth
2319 of the exhibit hall. During this Product Theater,
Dr. Kavita Kongara, MD and Kimberly Orleck, PA-C, MPH, RD will
share important clinical considerations in managing adult patients
with IBS-C, including interactive patient case studies, along with
efficacy and safety data from Ardelyx’s two phase three clinical
trials.
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 has two commercial products approved in the United States,
IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) as well as
early-stage pipeline candidates. Ardelyx has agreements for the
development and commercialization of tenapanor outside of the U.S.
Kyowa Kirin has received approval for PHOZEVEL® (tenapanor) for
hyperphosphatemia in Japan. A New Drug Application for tenapanor
for hyperphosphatemia has been submitted in China with Fosun
Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For
more information, please visit https://ardelyx.com/ and connect
with us on X (formerly known as Twitter), LinkedIn and
Facebook.
Investor and Media Contacts: Caitlin
Lowieclowie@ardelyx.com
Kimia Keshtbod kkeshtbod@ardelyx.com
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