Ardelyx's successful completion of Tenapanor's safety extension study for constipation-type irritable bowel syndrome January 4, 2018 Source: drugs crossing the headline of: peanuts Ardelyx today announced the successful completion of a phase III clinical study of Tenapanor's treatment of constipation-type irritable bowel syndrome (IBS-C), a safety extension of T3MPO-3. Volunteers of T3MPO-3 were those who had completed T3MPO-1 or T3MPO-2 studies. Both Phase III clinical trials were used to evaluate the efficacy of Tenapanor in the treatment of IBS-C. The T3MPO-3 results indicated that the average compliance rate for Tenapanor treatment was approximately 98% and was well tolerated in the 240 patients treated. Approximately 9.2% of patients in the study developed diarrhea, 1.7% of patients discontinued due to diarrhea, and the total discontinuation rate was only 2.1%. Ardelyx's R&D director said: "We are very excited to see that Tenapanor is very well tolerated in a study that lasts for more than a year, with very few patients discontinuing treatment. And the rate of diarrhea is lower than the first two studies. The T3MPO-1 and T3MPO-2 trials further suggest that the side effects of diarrhea occur early in the treatment and gradually return to normal over time. These results, along with such a large number of participants, confirm Tenapanor as a Effective and well tolerated IBS-C treatments have great potential" The results of the T3MPO-1 and T3MPO-2 studies, together with extensive safety data, are sufficient to support Ardelyx's submission of its first new drug application to the US Food and Drug Administration in the second half of 2018. Tenapanor Tenapanor is an inhibitor of intestinal sodium/proton exchanger subtype 3 (NHE3), developed by Ardelyx and belongs to a class of specific, almost unabsorbed oral drugs. Tenapanor has a unique mechanism of action that reduces sodium absorption in the diet by inhibiting or blocking gastrointestinal (GI) NHE3 transport, resulting in increased sodium in the intestinal tract, which in turn increases intestinal fluids and reduces constipation symptoms. In two phase III clinical trials completed for IBS-C treatment, tenapanor achieved primary and secondary endpoints with a significant improvement in IBS-C patients. In the T3MPO-2 study, treatment reached the primary end point at week 12, at which the tenapanor treatment group was reduced by 30% compared to the placebo group (36.5%: 23.7%, p < 0.001) for at least 6 weeks. Abdominal pain and increased one or more complete natural bowel movements (CSBM). In addition, the rate of abdominal pain response and the improvement of CSBM after tenapanor treatment were significant, and showed a consistent response throughout the 26 weeks of treatment. However, in the first two studies, there was a problem that a considerable proportion of patients had side effects of diarrhea, which was about 15%, and the control group was only 2%, which also led to the interruption of treatment caused by diarrhea. With a ratio of up to 6%, it is for this reason that Ardelyx will continue to conduct a long-term study, the T3MPO-3 study. According to the clinical research information of the drug delivery database, the drug was first developed by Ardelyx and AstraZeneca for the treatment of chronic kidney disease, because NHE3 receptor inhibitor can eliminate excess sodium in the body through feces (rather than urine). Ions, which may reduce the burden on the kidneys of patients with kidney disease. But unfortunately, the clinical phase II study was unsuccessful, and Ardelyx redeemed the drug from AstraZeneca alone to develop the drug and targeted the hyperphosphatemia and IBS-C. Reference: http://news.bioon.com/article/6668882.html
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