FREMONT, Calif. – Two months after slashing 28 percent of its workforce as part of a strategic review, Ardelyx, Inc. (ARDX) is celebrating with positive Phase III results for tenapanor, its irritable bowel syndrome with constipation (IBS-C).
Trial results show that tenapanor hit its primary and secondary endpoints by showing statistical significance in helping patients normalize bowel movements. Over a 12-week period, patients taking tenapanor 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. Additionally, Ardelyx said tenapanor patients also achieved statistical significance for the CSBM and abdominal pain responder rates in the six of 12 and nine of 12-treatment weeks. Patients taking tenapanor showed a consistent response across the 26 weeks of the study.
Tenapanor is designed to block the NHE3 transporter in the gastrointestinal (GI) tract to reduce the absorption of dietary sodium. Blocking NHE3 results in an increase in the amount of sodium in the gut. This increased sodium in the gut leads to an increase of fluid in the gut, loosening stool and helping to relieve constipation, the company said.
Mike Raab, president and chief executive officer of Ardelyx, said the Phase III data shows that tenapanor is a “game-changer for patients with IBS-C.” By normalizing bowel movements, the drug shows that it can have a significant impact on the lives of IBC-patients, Raab said in a statement.
“These results show that tenapanor has significant potential in the market and bolsters our commitment to identify the ideal collaboration partner to help ensure that we reach the most patients possible who would benefit from therapy,” Raab added.
Investors are agreeing with Raab’s assessment this morning. Shares of Ardelyx have shot up more than 53 percent this morning, hitting a high of $8.45 as of 10:30 a.m. Shares closed at $5.40 on Wednesday.
Ardelyx estimates that about 11 million people in the United States suffer from IBS-C, a gastrointestinal disorder characterized by significant abdominal pain and constipation. William Chey, a physician from the University of Michigan and researcher, said patients with IBS-C often have difficulty in day-to-day activities due to the discomfort of the gastrointestinal problem. Tenapanor, he said, can change that if approved.
Ardelyx is looking to take tenapanor to the U.S. Food and Drug Administration in 2018 for approval. There are already a few IBS-C treatments on the market, including Ironwood Pharmaceuticals (IRWD)’ Linzess. Tenapanor could also compete with Synergy Pharmaceuticals (SGYP)’ Trulance. The FDA accepted the supplemental New Drug Application for IBS-C in June. Trulance has already been approved by the FDA for the treatment of Chronic Idiopathic Constipation in adults.
Tenapanor is also in Phase III development for the treatment of hyperphosphatemia in patients with end-stage renal disease who are on dialysis.
October 12, 2017
By Alex Keown, BioSpace.com Breaking News Staff