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Ardelyx Reports Successful Phase 3 T3MPO-1 Trial of Tenapanor in Patients with IBS-C

FREMONT, Calif., May 12, 2017 /PRNewswire/ -- Ardelyx, Inc. (ARDX), a late-stage clinical company focused on enhancing the treatment of patients with cardiorenal and gastrointestinal (GI) diseases, today reported positive, topline results from the T3MPO-1 trial, the first of two Phase 3 trials evaluating tenapanor for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). Tenapanor is Ardelyx's investigational, minimally systemic, small-molecule NHE3 inhibitor.

The T3MPO-1 trial achieved statistical significance for the primary endpoint and seven of eight secondary endpoints. The primary endpoint, the combined responder rate for six of 12 weeks, showed that a greater proportion of tenapanor-treated patients compared to placebo-treated patients (27.0% vs 18.7%, p=0.02) had at least a 30 percent reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements (CSBM) in the same week for at least six of the 12 weeks of the treatment period. Tenapanor was well-tolerated, consistent with the experience across previous clinical trials.

"We're pleased to have achieved the primary endpoint in the T3MPO-1 trial," said Mike Raab, president and chief executive officer of Ardelyx. "IBS-C is an extremely difficult, life-altering condition, and despite advancements, there remains a...