ARDELYX, INC. (NASDAQ:ARDX) Files An 8-K Regulation FD DisclosureItem 7.01
(³ 30% abdominal pain reduction)
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. ExhibitEX-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.
