- The company was formerly known as Nteryx, Inc. and changed its name to Ardelyx, Inc. in June 2008.
- Ardelyx, Inc. was founded in 2007 and is headquartered in Fremont, California.
Key stats and ratios
| Q1 (Mar '17) | 2016 | |
| Net profit margin | - | - |
| Operating margin | - | - |
| EBITD margin | - | - |
| Return on average assets | -56.04% | -68.10% |
| Return on average equity | -62.27% | -74.42% |
| Employees | 93 |
Address
34175 Ardenwood Blvd
FREMONT, CA 94555-3653
United States
FREMONT, CA 94555-3653
United States
Ardelyx Reports Successful Phase 3 T3MPO-1 Trial of Tenapanor in Patients with IBS-C
PR Newswire PR NewswireMay 12, 2017
The T3MPO-1 trial achieved statistical significance for the primary endpoint and seven of eight secondary endpoints. The primary endpoint, the combined responder rate for six of 12 weeks, showed that a greater proportion of tenapanor-treated patients compared to placebo-treated patients (27.0% vs 18.7%, p=0.02) 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. Tenapanor was well-tolerated, consistent with the experience across previous clinical trials.
"We're pleased to have achieved the primary endpoint in the T3MPO-1 trial," said Mike Raab, president and chief executive officer of Ardelyx. "IBS-C is an extremely difficult, life-altering condition, and despite advancements, there remains a strong need for new, innovative treatments. In this trial, tenapanor demonstrated clinical activity across a large number of study parameters and had a favorable safety profile consistent with previous clinical experience. With a differentiated mechanism of action, we believe tenapanor has the potential to augment the care of patients with IBS-C."
T3MPO-1 Trial Design
T3MPO-1 was a 12-week, double-blind, placebo-controlled, multi-center, randomized trial with a four-week, randomized withdrawal period conducted in a total of 610 patients meeting the ROME III criteria for the diagnosis of IBS-C. Patients were randomized one to one to receive either 50 mg of tenapanor (n=309) or placebo (n=301) twice-daily. The trial included a two-week screening period, during which patients with active disease, based on bowel movement frequency and abdominal pain score recorded in a daily phone diary, were randomized into the trial.
PR Newswire PR NewswireMay 12, 2017
The T3MPO-1 trial achieved statistical significance for the primary endpoint and seven of eight secondary endpoints. The primary endpoint, the combined responder rate for six of 12 weeks, showed that a greater proportion of tenapanor-treated patients compared to placebo-treated patients (27.0% vs 18.7%, p=0.02) 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. Tenapanor was well-tolerated, consistent with the experience across previous clinical trials.
"We're pleased to have achieved the primary endpoint in the T3MPO-1 trial," said Mike Raab, president and chief executive officer of Ardelyx. "IBS-C is an extremely difficult, life-altering condition, and despite advancements, there remains a strong need for new, innovative treatments. In this trial, tenapanor demonstrated clinical activity across a large number of study parameters and had a favorable safety profile consistent with previous clinical experience. With a differentiated mechanism of action, we believe tenapanor has the potential to augment the care of patients with IBS-C."
T3MPO-1 Trial Design
T3MPO-1 was a 12-week, double-blind, placebo-controlled, multi-center, randomized trial with a four-week, randomized withdrawal period conducted in a total of 610 patients meeting the ROME III criteria for the diagnosis of IBS-C. Patients were randomized one to one to receive either 50 mg of tenapanor (n=309) or placebo (n=301) twice-daily. The trial included a two-week screening period, during which patients with active disease, based on bowel movement frequency and abdominal pain score recorded in a daily phone diary, were randomized into the trial.
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