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Ardelyx Reports Successful Phase 3 T3MPO-1 Trial of Tenapanor in Patients with IBS-C

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.

T3MPO-1 Topline Efficacy Results
During the two-week screening period, the baseline mean weekly CSBMs were 0.2 and the mean abdominal pain score was 6.3 (on a 0 - 10 scale where 0 is no pain and 10 is very severe).
Key data are as follows:

Table 1

6 of 12 Treatment Week Results

Tenapanor

Placebo

P value

Combined responder (primary endpoint)
(abdominal pain and CSBM responder)

27.0%

18.7%

p=0.02

CSBM responder
(increase ≥ 1 CSBM from baseline)

33.9%

29.4%

p=0.27

Abdominal pain responder
(≥ 30% abdominal pain reduction)

44.0%

33.1%

p=0.008


Table 2

9 of 12 Treatment Week Results

Tenapanor

Placebo

P value

Combined responder
(abdominal pain and CSBM responder)

13.7%

3.3%

p<0.001

CSBM responder
(increase ≥ 1 CSBM from baseline and ≥3 CSBM/week)

16.9%

5.0%

p<0.001

Abdominal pain responder
(≥ 30% abdominal pain reduction)

30.3%

19.4%

p=0.003


Table 3

Durable Responder Results
(9 of 12 and >3 of last 4 treatment weeks)

Tenapanor

Placebo

P value

Combined responder
(abdominal pain and CSBM responder)

13.0%

3.3%

p<0.001

CSBM responder
(increase ≥ 1 CSBM from baseline and ≥3 CSBM/week)

16.0%

4.7%

p<0.001

Abdominal pain responder
(≥ 30% abdominal pain reduction)

29.3%

19.4%

p=0.006

"When we look at the totality of the topline results from T3MPO-1, we believe tenapanor has the potential to offer benefit to patients with IBS-C," said David Rosenbaum, Ph.D., chief development officer of Ardelyx. "We are encouraged that the nine of 12 week data demonstrate a durable and sustained response for constipation and abdominal pain, as well as a...


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