ARDELYX, INC. (NASDAQ:ARDX) Files An 8-K Regulation FD Disclosure

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ARDELYX, INC. (NASDAQ:ARDX) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.

(³ 30% abdominal pain reduction)

34.8 % 26.7 % p=0.028

Tenapanor was well-tolerated, consistent with the experience across previous clinical trials. The only adverse events observed in greater than two percent of patients in the tenapanor-treated group that were also greater than placebo were diarrhea (16.0% vs. 3.7%), flatulence (3.1% vs. 1.0%), nasopharyngitis (4.4% vs. 3.7%) and abdominal distension (3.4% vs. 0.3%). The placebo adjusted discontinuation rate due to diarrhea was 5.8percent.

Based on positive results from two, positive Phase 3 trials, the Company is on track to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration for tenapanor for the treatment of IBS-C in the second half of 2018. Final, detailed results from the study are expected to be presented at a medical meeting in 2018.

Patients who have completed T3MPO-1 and T3MPO-2 are eligible to enter T3MPO-3, the Company’s 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 and the results of the trial will be included in the NDA submission for tenapanor for the treatment of patients with IBS-C.

T3MPO-2 Primary and Secondary Endpoint Definitions

Primary Endpoint:

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.

Secondary Endpoints:

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 30percent decrease in abdominal pain from baseline 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. Normal bowel function is characterized by at least three bowel movements a week up to three bowel movements a day.
Abdominal pain responder rate (9/12 week): A nine of 12-week abdominal pain responder is a patient that has at least a 30percent decrease in abdominal pain from baseline 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.
Item 7.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1 Corporate presentation of Ardelyx, Inc.


ARDELYX, INC. Exhibit
EX-99.1 2 d648753dex991.htm EX-99.1 EX-99.1 ARDELYX REPORTS POSITIVE T3MPO-2 PHASE 3 TRIAL RESULTS IN IBS-C OCTOBER 11,…
To view the full exhibit click here

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.

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