Ardelyx (NASDAQ:ARDX) has successfully completed the safety extension portion of its Phase 3 T3MPO program, which supports the registration of tenapanor for the treatment of patients with irritable bowel syndrome with constipation (IBS-C).
Results showed a mean tenapanor compliance rate of ~98% among the 240 patients treated. The overall discontinuation rate in the study was just 2.1%.
The positive results from both the T3MPO-1 and T3MPO-2 studies, combined with the extensive safety data, support Ardelyx's plans to submit its first NDA to the FDA for this indication in H2 2018.
Tenapanor is an oral, experimental medication. Tenapanor acts by inhibiting, or blocking, the NHE3 transporter in the gastrointestinal tract to reduce the absorption of dietary sodium, leading to increased sodium within the gut.
Shares are up 6% premarket on light volume.
Subscribe for full text news in your inbox