Ardelyx, Inc. (ARDX - Free Report) announced meeting the primary endpoint in a second phase III study — T3MPO-2 — evaluating tenapanor in patients with irritable bowel syndrome with constipation (IBS-C). Based on the positive top-line data from this study as well as previously completed T3MPO-1 study, the company is planning to file a new drug application (“NDA”) in the second half of 2018.
Ardelyx’s stock surged more than 36% in after-market trading on Wednesday, following the announcement. However, shares of the company are down 62% so far this year, significantly underperforming the industry’s gain of 0.7% in the period.
Data from the T3MPO-2 study showed that the candidate achieved the primary endpoint and all secondary endpoint with statistical significance. The candidate reduced abdominal pain by 30% in greater number of patients compared to placebo (36.5% vs. 23.7%) and increased one or more complete spontaneous bowel movements (CSBM) in the same week for at least six weeks in the 12-week treatment period. The improvements were consistent over the 26 weeks of study.
In May, the company had announced positive data from the first phase III study (T3MPO-1) on tenapanor for the same indication. Meanwhile, another phase III study, T3MPO-3, is evaluating the candidate in this indication where patients are treated for up to one year. The study is expected to be complete by 2017. Data from this study will also be included in the NDA.
Ardelyx is currently focusing on finding a collaboration partner to expand its reach through successful commercialization.
The candidate is also being evaluated in a phase III study in hyperphosphatemia in patients who are suffering from end-stage renal disease and are on dialysis.
IBS-C is a gastrointestinal disorder in which patients suffer from significant abdominal pain and constipation. Ardelyx estimates 11 million patients with IBS-C in the United States.
However, there are other companies marketing or developing drugs for the treatment of IBS-C in the United States. Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) along with its partner Allergan plc (AGN - Free Report) markets Linzess for IBS-C. Synergy Pharmaceuticals Inc.’s (SGYP - Free Report) is developing its chronic idiopathic constipation drug Trulance for the treatment of IBS-C with an application for label expansion under review. A decision for Trulance is expected in January next year.
Ardelyx carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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