Ardelyx Announces Publication of Positive Results from T3MPO-3 Long-Term Open-Label Safety Trial of Tenapanor for IBS-C in the Journal of Neurogastroenterology and Motility
28 September 2023 - 2:02PM
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,
today announced the publication of results from the T3MPO-3
long-term open-label safety trial of IBSRELA® (tenapanor) for
irritable bowel syndrome with constipation (IBS-C) in the Journal
of Neurogastroenterology and Motility (JNM). The paper, titled
“Long-term safety of tenapanor in patients with irritable bowel
syndrome with constipation in the T3MPO-3 study,” can be accessed
in the current online edition of the publication. IBSRELA,
discovered and developed by Ardelyx, has a first-in-class mechanism
of action and is approved by the U.S. Food and Drug Administration
to treat IBS-C in adults.
In this long-term open-label safety study, tenapanor showed
acceptable tolerability with a safety profile consistent with that
reported in the prior studies.
“The T3MPO-3 results provide important data on IBSRELA’s safety
profile in a longer-term setting,” said David Rosenbaum, Ph.D.,
chief development officer of Ardelyx. “We are pleased by the
publication of these results in this distinguished gastroenterology
journal as we continue to grow awareness of IBSRELA as another
option for people with IBS-C.”
Anthony Lembo, M.D., Director of Research for Cleveland Clinic’s
Digestive Disease & Surgery Institute, added, “These long-term
results provide further support for IBSRELA as a valuable treatment
option for people with IBS-C. Adults with IBS-C frequently suffer
from constipation, abdominal pain, bloating and other symptoms,
which has a significant impact on their quality of life. IBSRELA,
with its differentiated mechanism of action and clinically
validated efficacy and tolerability, provides an important option
for these patients seeking relief from their symptoms.”
Patients who completed T3MPO-1 or T3MPO-2, the two Phase 3
trials of tenapanor for IBS-C, were eligible for enrollment in
T3MPO-3. The T3MPO-3 trial enrolled a total of 312 patients of
which 262 patients completed treatment. Patients received
open-label tenapanor 50 mg twice a day for up to an additional 39
(T3MPO-1) or 26 (T3MPO-2) weeks. Ninety patients received ≥52 weeks
of tenapanor. Treatment-emergent adverse events (TEAEs) were
reported in 117 of the 312 (37.5%) patients in the entire T3MPO-3
population and in 52 of the 90 (57.8%) patients who received ≥52
weeks of tenapanor. Overall, 10.6% of patients experienced
diarrhea. TEAEs led to limited discontinuations (13 patients/4.2%)
in the entire T3MPO-3 safety population, (11 patients/3.5%) due to
diarrhea, (1.7%/1 patient) due to flatulence and abnormal GI
sounds. Tenapanor was generally well tolerated with diarrhea being
the most commonly reported adverse event.
The article is available online and can be accessed here.
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 an inadequate response or intolerance to a
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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