..This Month's Clinical Focus: GASTROENTEROLOGY..
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biologic may treat Ulcerative Colitis, too
Application submitted to FDA seeking approval of STELARA® (ustekinumab) for treatment of moderately to severely active ulcerative colitis
is the first and only biologic targeting interleukin (IL)-12 and IL-23 cytokines, which evidence suggests play an important role in inflammation associated with auto-immune conditions, such as ulcerative colitis. STELARA is approved in many countries, including
the U.S., for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis and moderate to severe Crohn's disease.
The submission is based on data from the Phase 3 UNIFI global clinical development program, which included two studies (one induction and one maintenance study) evaluating the efficacy and safety of STELARA for the treatment of moderately to severely active
ulcerative colitis in adults.
Data from the Phase 3 induction study were recently presented at the 2018 American College of Gastroenterology and United European Gastroenterology Week annual meetings.
Results from the induction phase of the Phase 3 UNIFI study show that treatment with a single IV dose of STELARA induced
clinical remission in a significantly greater proportion of UC patients at week 8, compared with placebo, at both doses studied. Major secondary endpoints including the proportion of patients in clinical response, endoscopic healing, as well as improvement
in health-related quality of life, were also significantly higher at week 8 among patients receiving STELARA compared with patients receiving placebo. About 50 percent of study participants are considered biologic refractory, and 17 percent have a history
of inadequate response or intolerance to an anti-TNF and/or Entyvio* (vedolizumab).
SOURCE: Used by Permission of PRNewswire
for Tenapanor for the Treatment of Patients with IBS-C Accepted at FDA
Tenapanor is a minimally-systemic small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium transporter
NHE3 and reduce sodium uptake from the gut.
Ardelyx's NDA submission is supported by a clinical package encompassing more than 3,100 patients and healthy volunteers
who have participated in Ardelyx trials and an extensive clinical and preclinical data package supporting the excellent safety profile. The data include results from the completed IBS-C registration T3MPO program, which consisted of two Phase 3 trials, T3MPO-1
and T3MPO-2, and a long-term safety extension trial, T3MPO-3. Both the T3MPO-1 and T3MPO-2 trials achieved statistical significance for their primary endpoint and demonstrated that tenapanor had a durable effect on reducing constipation and abdominal pain
that patients with IBS-C experience. The favorable safety profile of tenapanor, which has been shown across all trials, was further supported by the completed T3MPO-3 study.
(1) Tenapanor blocks NHE3, increasing sodium in the gut; NHE3 transports sodium in exchange for protons
(2) Elevated proton levels in cells selectively increase tight junction resistance to phosphate transport
(3) Increased tight junction resistance reduces gut phosphate absorption
About Tenapanor for IBS-C
Tenapanor is a minimally-systemic small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium transporter NHE3 and reduce sodium absorption
in the GI tract, thus increasing intestinal fluid. In addition, data from preclinical studies suggest that tenapanor reduces abdominal pain caused by IBS-C through the inhibition of TRPV-1 dependent signaling. TRPV-1, better known as the "hot chili pepper
receptor," is a well-established pain target known for transmitting painful stimuli from a variety of sources including heat, protons and inflammatory molecules. .
Used by Permission of PRNewswire
Image credits: FDA Logo Public Domain Free Lic CC0; Tenapanor molecule diagram courtesy of Ardelyx
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