Core Insights - Ardelyx, Inc. announced positive results from a post hoc analysis of its IBS-C clinical development program, indicating that Tenapanor (IBSRELA) provides earlier and sustained symptom relief for patients with irritable bowel syndrome with constipation [1][2][4] Group 1: Clinical Findings - The post-hoc analysis pooled data from three clinical trials, showing that patients taking Tenapanor experienced improvements in bowel movement frequency as early as two weeks and significant relief from abdominal symptoms within 4-5 weeks [2] - Continued therapy for 12 weeks increased the likelihood of reporting meaningful symptom improvement across multiple symptoms, emphasizing the importance of sustained treatment [3] Group 2: Practical Implications - The analysis offers week-by-week insights into the timing and durability of Tenapanor's effects, aiding healthcare providers in setting realistic expectations for patients [4] - The sustained response, defined as improvement maintained over consecutive weeks, was observed in some patients, indicating that ongoing therapy is beneficial for achieving symptom relief [4] Group 3: Safety and Tolerability - No new or unexpected safety findings were reported, with Tenapanor generally well tolerated; the most common adverse event was mild-to-moderate diarrhea [4] - In clinical trials, diarrhea occurred in 16% of Tenapanor-treated patients compared to 4% in the placebo group, with severe diarrhea reported in 2.5% of patients [10][9] Group 4: Product Information - IBSRELA (Tenapanor) is a first-in-class retainagogue approved by the FDA for treating IBS-C in adults, acting as a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3) [1][6] - The drug works by reducing sodium absorption in the intestines, which helps retain water content and improves stool consistency while also reducing abdominal pain [6] Group 5: Company Overview - Ardelyx is a biopharmaceutical company focused on developing innovative medicines for unmet medical needs, with two commercial products approved in the U.S., including IBSRELA [12] - The company's pipeline includes ongoing Phase 3 development of Tenapanor for chronic idiopathic constipation and a next-generation NHE3 inhibitor [12]

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Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs [1][12] - The company has two commercial products approved in the United States: IBSRELA and XPHOZAH, both containing the active ingredient tenapanor [12] Product Information - XPHOZAH (tenapanor) is the first and only phosphate absorption inhibitor (PAI) approved by the U.S. FDA for reducing serum phosphorus in adults with chronic kidney disease (CKD) on dialysis [2][11] - It is indicated as add-on therapy for patients who have an inadequate response to phosphate binders or are intolerant to any dose of phosphate binder therapy [11] - XPHOZAH operates through a unique mechanism that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily [2][6] Clinical Study Insights - The OPTIMIZE Study was a randomized, open-label trial involving 330 patients with CKD on dialysis and hyperphosphatemia, aimed at evaluating methods for initiating XPHOZAH to optimize phosphorus management [3] - A post-hoc analysis of this study has been accepted for presentation at the National Kidney Foundation Spring Clinical Meetings [1][4] Safety and Efficacy - Diarrhea was the most common side effect reported in clinical trials, occurring in 43-53% of patients, with severe diarrhea reported in 5% of patients [10] - The majority of diarrhea events were mild-to-moderate and typically resolved over time or with dose reduction [10] Industry Context - Hyperphosphatemia is a serious condition affecting the majority of the 550,000 patients in the U.S. with CKD on maintenance dialysis, necessitating effective management strategies [7] - The KDIGO treatment guidelines recommend lowering elevated phosphate levels toward the normal range of 2.5-4.5 mg/dL [7]