Ardelyx reports positive phase 3 data, but shares fall hard premarket

Ardelyx says it has hit its primary endpoint and most of its secondary endpoints in a late-stage test of its IBS (with constipation) candidate tenapanor, but investors were spooked as its shares spiraled downward premarket.

The topline results from the T3MPO-1 trial, the first of two phase 3 tests in IBS-C in more than 600 patients, hit its primary endpoint, showing that a greater proportion of tenapanor-treated patients compared to placebo-treated patients (27% vs 18.7%) had at least a 30% reduction in abdominal pain.

ChemSpider 2D Image | Tenapanor | C50H66Cl4N8O10S2

It also hit seven of the eight secondary endpoints, missing the target in bowel movement rates, and there were some AE issues with tenapanor as compared with a dummy treatment, seeing higher rates of diarrhea (14.6% vs 1.7%) and slightly more for nausea (2.6% vs 1.7%).

Patients pulling out of the trial due to diarrhea were 5.9% for tenapanor, compared to just 0.6% for the placebo group. More details from the study will be published down the line.

“We’re pleased to have achieved the primary endpoint in the T3MPO-1 trial,” said Mike Raab, president and CEO of Ardelyx.

“IBS-C is an extremely difficult, life-altering condition, and despite advancements, there remains a strong need for new, innovative treatments. With a differentiated mechanism of action [the drug is a small-molecule NHE3 inhibitor], we believe tenapanor has the potential to augment the care of patients with IBS-C.”

A second phase 3 trial, T3MPO-2, is expected to report in the fourth quarter and is a 26-week study of tenapanor in IBS-C. The biotech hopes to use data from both trials to help it make its case to regulators in the future.

Back in February, tenapanor also hit its marks in a phase 3 hyperphosphatemia (elevated levels of phosphate in the blood) test, but that came after a year of struggles for the biotech and some major adverse events for diarrhea in former studies.

The company’s shares were down a major 38% in early trading this morning, potentially on the still higher-than-placebo rates of diarrhea, given its past problems in the area.

May 13, 2017


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