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Ardelyx Showcased Encouraging Data on Treatment Satisfaction and Efficacy of IBSRELA® (tenapanor) for IBS-C - GlobeNewswire

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Ardelyx Showcased Encouraging Data on Treatment Satisfaction and Efficacy of IBSRELA® (tenapanor) for IBS-C  GlobeNewswire


WALTHAM, Mass., Sept. 11, 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, 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.

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  • Jeffrey Roberts changed the title to Ardelyx Showcased Encouraging Data on Treatment Satisfaction and Efficacy of IBSRELA® (tenapanor) for IBS-C - GlobeNewswire

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