Tenapanor Agreement

View original content for multimedia download:www.prnewswire.com/news-releases/ardelyx-receives-fda-approval-for-ibsrela-tenapanor-an-nhe3-sodium-transport-inhibor-for-the-treat Irritant-intestinal syndrome with constipation-300917407.html Indications and Usageibsrela (Tenapanor) is indicated in the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. About Tenapanor Tenapanor, discovered and developed by Ardelyx, is a first-class, proprietary, minimally absorbed, oral, experimental drug in late clinical development. It has a unique mechanism of action that works in IBS-C by inhibiting or blocking the NHE3 transporter in the gastrointestinal tract (GI) to reduce dietary sodium absorption, resulting in an increase in the amount of sodium intestines. This increase in sodium increases the water in the intestine that dissolves the stool, helps relieve constipation. Preclinical studies have shown that tenapanor can work to reduce abdominal pain caused by IBS-C by inhibiting TRPV-1-dependent signaling. Ardelyx has also seen a desired benefit in the abdominal pain component of IBS-C in its clinical studies to date. Two Phase 3 clinical studies of tenepanor in IBS-C have been completed by Ardelyx: having statistical significance for the primary endpoint, the combined response rate for six weeks out of twelve, defined as a 30 percent reduction in abdominal pain and an increase of one or more complete bowel movements (DOC) in the same week compared to the initial value, for at least six of the 12 weeks of the treatment period. Tenpanor was well tolerated in both studies. In the second half of 2018, Ardelyx plans to reapply for drugs seeking approval of IBS-C by the U.S.

Food and Drug Administration (FDA) for the treatment of IBS-C. „Ardelyx can now accelerate the clinical development of Tenapanor to meet the needs of two underserved patient populations. We are grateful for AstraZeneca`s significant investments in the NHE3 program and have been fortunate to have them as partners,“ added Raab. Under the agreement, Knight will pay a total of up to CAD 25 million in payments, including a down payment, development and distribution stones and double-digit royalties for net sales.