Safety data for RDX 5791 in irritable bowel syndrome with constipation shows drug well tolerated.- Ardelyx.

Ardelyx announced that new data from its long-term safety trial of RDX 5791 (tenapanor) for irritable bowel syndrome with constipation (IBS-C), the T3MPO-3 trial, were presented at the American College of Gastroenterology (ACG) 2018 Annual Meeting. The T3MPO-3 trial enrolled a total of 240 patients who completed either the T3MPO-1 or T3MPO-2 Phase III trials. All participants in T3MPO-3 received 50 mg of tenapanor twice-daily for up to 55 weeks. Importantly, results from T3MPO-3 showed a mean compliance rate with tenapanor of approximately 98 percent. Overall, tenapanor was well-tolerated, with the most common adverse event being diarrhea (9.2%). There were limited discontinuations (2.1%), with only 1.7 percent of patients discontinuing due to diarrhea. The poster (P0338) was titled "An Open Label Long-Term Safety Trial (T3MPO-3) of Tenapanor in Patients with Irritable Bowel Syndrome with Constipation (IBS-C)".

Comment: Ardelyx recently submitted a New Drug Application for marketing authorization of tenapanor for the treatment of people with IBS-C to the FDA, which was supported by a robust set of nonclinical studies and an extensive clinical data package in more than 3,100 people supporting the efficacy and safety profile of tenapanor. The data include results from the completed IBS-C registration T3MPO program, which consisted of two Phase III trials, T3MPO-1 and T3MPO-2, and the long-term safety extension trial, T3MPO-3. Both the T3MPO-1 and T3MPO-2 trials achieved statistical significance for their primary endpoint and demonstrated the ability of tenapanor to have a durable effect on reducing the constipation and abdominal pain that patients with IBS-C experience. The favorable safety profile of tenapanor, which has been shown across all trials, was further supported by the completed T3MPO-3 study.