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

WALTHAM, Mass., Sept. 28, 2023 (GLOBE NEWSWIRE) -- 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

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