ARDELYX, INC. (NASDAQ:ARDX) Files An 8-K Other Events
Item8.01
| Other Events. |
On May12, 2017, Ardelyx, Inc. (the Company) announced
topline results from the T3MPO-1 trial, the first of two Phase 3
trials evaluating tenapanor for the treatment of patients with
irritable bowel syndrome with constipation (IBS-C).
Tenapanor is the Companys investigational, minimally systemic,
small-molecule NHE3 inhibitor. 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 (CSBMs) 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.
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 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.
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 | % | p0.001 | |||||||
|
CSBM responder (increase 1 CSBM from baseline) |
16.9 | % | 5.0 | % | p0.001 | |||||||
|
Abdominal pain responder ( 30% abdominal pain reduction) |
30.3 | % | 19.4 | % | p=0.003 |
Table 3
|
Durable Overall Responder Rate 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 | % | p0.001 | |||||||
|
CSBM responder (increase 1 CSBM from baseline) |
16.0 | % | 4.7 | % | p0.001 | |||||||
|
Abdominal pain responder ( 30% abdominal pain reduction) |
29.3 | % | 19.4 | % | p=0.006 |
Tenapanor was well-tolerated, consistent with the experience
across previous clinical trials. The only adverse events observed
in more than two percent of patients treated with tenapanor, as
compared with placebo, were diarrhea (14.6% vs 1.7%) and nausea
(2.6% vs 1.7%). Discontinuations due to diarrhea were 5.9 percent
for the tenapanor-treated patients, compared to 0.6 percent for
the placebo group, based on the preliminary results.
A second Phase 3 trial, T3MPO-2, a 26-week study evaluating
tenapanor for the treatment of patients with IBS-C is ongoing
with data expected early in the fourth quarter of 2017. Patients
who have completed T3MPO-1 and T3MPO-2 are eligible to enter
T3MPO-3, the Companys open-label, long-term safety trial where
patients can continue to receive tenapanor for up to one year.
T3MPO-3 is expected to conclude in late 2017.
T3MPO-1 Primary and Key Secondary Endpoint
Definitions
|
Combined responder rate (6/12 week): A six of 12 week combined responder is a CSBM responder and an abdominal pain responder during the same week for six of 12 weeks. |
|
CSBM responder rate (6/12 week): A six of 12 week CSBM responder is a patient that has an increase of at least one CSBM from baseline during a week for six of 12 weeks. |
|
Abdominal pain responder rate (6/12 week): A six of 12 week abdominal pain responder is a patient that has at least a 30 percent decrease in abdominal pain during a week for six of 12 weeks. |
|
Combined responder rate (9/12 week): A nine of 12 week combined responder is a nine of 12 week CSBM responder and an abdominal pain responder during the same week for nine of 12 weeks. |
|
CSBM responder rate (9/12 week): A nine of 12 week CSBM responder is a patient that has an increase of at least one CSBM from baseline and at least three CSBMs during a week for nine of 12 weeks. |
|
Abdominal pain responder rate (9/12 week): A nine of 12-week abdominal pain responder is a patient that has at least a 30 percent decrease in abdominal pain during a week for nine of 12 weeks. |
|
Durable responder rates (9/12 week): All three durable responder endpoints combined responder rate, CSBM responder rate and abdominal pain responder rate are identical to the nine of 12 week responder endpoints, except the response must also occur in three of the last four treatment period weeks. |
About ARDELYX, INC. (NASDAQ:ARDX)
Ardelyx, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of minimally systemic therapeutic drugs that work in the gastrointestinal (GI) tract to treat GI and cardio-renal diseases. The Company operates through research, development and commercialization of biopharmaceutical products segment. It has discovered and designed its lead product candidate, tenapanor, which is a minimally systemic small molecule that acts locally in the GI tract to inhibit the sodium transporter sodium-hydrogen exchanger 3 (NHE3) and reduce sodium and phosphorus uptake from the gut. It is evaluating tenapanor in over two pivotal Phase III clinical studies in patients with constipation-predominant irritable bowel syndrome (IBS-C). It is developing RDX022 for the treatment of hyperkalemia. RDX022 is its oral, non-absorbed potassium-binder. Its development programs also include RDX009 Program, RDX013 Program and RDX011 Program. ARDELYX, INC. (NASDAQ:ARDX) Recent Trading Information
ARDELYX, INC. (NASDAQ:ARDX) closed its last trading session down -0.35 at 12.25 with 200,861 shares trading hands.