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Ardelyx生物制药公司宣布其治疗便秘型肠易激综合症新药替那帕诺(tenapanor)的Ⅱb期临床试验获阳性结果,50 mg组达到主终点,有完全自发性肠运动反应人数增加。此药是一种小分子胃肠道NHE3钠转运体抑制剂,可使食物中大部分钠不被吸收入血液而滞留在肠内,口服试验表明此药也阻止磷的吸收。临床试验为Ⅱb期随机、双盲、安慰剂对照、多中心研究,评价5、20和50 mg 3个剂量水平2次/d对371名便秘型肠易激综合征患者连续12周的疗效和安全性。患者在12周内凡有6周大便次数较基线时增加者为有效
Ardelyx BioPharma Announces Positive Phase IIb Clinical Trial of Tenapanor, a New Drug for the Treatment of Constipated Irritable Bowel Syndrome Arrelyx Biopharmaceuticals has achieved a primary endpoint in the 50 mg group with an increased number of patients with completely spontaneous intestinal motility. This drug is a small molecule gastrointestinal NHE3 sodium transporter inhibitor, most of the sodium in the food can not be absorbed into the bloodstream and remain in the intestine. Oral tests show that the drug also blocks the absorption of phosphorus. The clinical trial was a randomized, double-blind, placebo-controlled, multicentre study of phase IIb in which the efficacy and efficacy of 3 doses of 5, 20 and 50 mg twice daily for 37 weeks in patients with constipation-predominant irritable bowel syndrome for 12 weeks safety. Patients who had a 6-week stool frequency over 12 weeks were more effective than those at baseline