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Ardelyx reports Phase 3 trial of Tenapanor a success

Wednesday, February 15, 2017 8:46
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Ardelyx, Inc. (NASDAQ:ARDX) shares were up nearly 5% on Wednesday after reporting that the Phase 3 clinical trial evaluating the efficacy and safety of tenapanor as a treatment for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis met its primary endpoint and was generally well-tolerated.

Tenapanor is intended as a treatment for hyperphosphatemia in patients with end-stage renal disease.

The clinical-stage company which is focused on enhancing the treatment of patients with cardiorenal and gastrointestinal (GI) diseases said the responder population (n=80 out of 164) had a mean reduction in serum phosphorus from baseline to the end of the eight-week treatment period of 2.56 mg/dL, with a reduction of up to 5.7 mg/dL.

Notably, in this group, 33% of patients had a reduction in serum phosphorus of greater than 3 mg/dL.

The study demonstrated a statistically significant difference in serum phosphorus levels from the end of the eight-week treatment period to the end of the four-week randomized withdrawal period between the tenapanor-treated group and the placebo-treated group in the responder patient population (mean -1.01 mg/dL, median of -1.3 mg/dL) and met its primary endpoint (95% CI -1.44, -0.21; LSmean -0.82 mg/dL; p=0.01). Only 7.8 percent of patients discontinued treatment due to GI side effects.

Hyperphosphatemia is a condition of higher than normal levels of serum phosphorus in the blood that is estimated to affect more than 745,000 people with ESRD who are on dialysis in major developed countries 1 .

“The reduction in serum phosphorus in many patients treated with tenapanor is remarkable. These data validate tenapanor’s unique mechanism of action and its potential to be the first non-phosphate binder treatment for this difficult-to-manage disorder,” said Geoff Block M.D ., director, clinical research at Colorado Kidney Care, and a Phase 3 investigator.

“My patients are often required to take more than 19 pills per day, of which, nearly half are phosphate binders. The efficacy of tenapanor with only a few small pills, combined with its GI tolerability, has the potential to change the way in which we treat our patients in the future. I look forward to participating in the next Phase 3 study and evaluating the full potential of this novel agent,” he added.

Tenapanor was well-tolerated in the trial. In the eight-week treatment period, the only adverse event that affected more than five percent of patients treated with tenapanor was diarrhea (39 percent), a patient-reported side effect of loosened stool or increased frequency in bowel movements regardless of magnitude. In the four-week randomized withdrawal period, there was a diarrhea rate of 1.2% for patients treated with tenapanor compared with 2.4% on placebo. Treatment discontinuations due to diarrhea for patients treated with tenapanor was 7.8% (n=17). There were no discontinuations due to diarrhea in the randomized withdrawal period.

Ardelyx shares were up 4.4% at $11.95 on Wednesday.

Story by ProactiveInvestors


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