Ardelyx Inc.'s stock price rose more than 25% after the company said tenapanor significantly reduced blood phosphate levels in chronic kidney disease patients on dialysis during a late-stage study.
Results from the phase 3 trial, named Amplify, showed that tenapanor taken with phosphate binders significantly reduced blood phosphate levels in chronic kidney disease patients on dialysis compared to those who received a placebo-binder combination.
The Fremont, Calif.-based biotechnology company said tenapanor met the main goal of the study and reduced the quantity of phosphate in the blood of kidney patients with high levels of the inorganic chemical. High blood phosphate results in an accumulation of calcium salts in the blood vessels, which increases the risk of death from heart diseases.
The average reduction in blood phosphorus for the tenapanor combination group after four weeks of treatment was 0.84 milligrams per deciliter. In comparison, the mean reduction in the placebo arm was 0.19 milligrams per deciliter.
In addition, about half of the patients in the tenapanor arm had a blood phosphate level of less than 5.5 mg/dL. Only 23.5% of patients getting the placebo-binder combination had a lower amount in their blood.
Ardelyx President and CEO Mike Raab said the company expects to get results from another phase 3 trial in the fourth quarter of 2019. "With additional positive results from that trial, we will complete our new drug application for tenapanor, encompassing two indications: monotherapy and combination therapy for the treatment of hyperphosphatemia," he added.
The company submitted an application for tenapanor with the U.S. Food and Drug Administration for the treatment of irritable bowel syndrome with constipation, a gastrointestinal disorder resulting in significant abdominal pain, in September 2018.
Ardelyx has licensed development and commercialization rights for tenapanor as a treatment for both these indications in Canada, China and Japan to Knight Therapeutics Inc., Shanghai Fosun Pharmaceutical (Group) Co. Ltd. and Kyowa Kirin Co. Ltd., respectively.
Ardelyx's stock price was up 26.47% to $4.30 as of 11:54 a.m. ET on Sept. 3.
