Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IW-3718 · 3 trials · 3 indications
The WHSS is defined as the weekly average of the DHSS. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement.
The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| 1500 mg IW-3718 BID | EXPERIMENTAL | Three 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day. |
| Placebo | PLACEBO_COMPARATOR | Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day. |
| Control | PLACEBO_COMPARATOR | Matching placebo twice daily |
| 500 mg IW-3718 | EXPERIMENTAL | 500 mg IW-3718 twice daily |
| 1000 mg IW-3718 | EXPERIMENTAL | 1000 mg IW-3718 twice daily |
| 1500 mg IW-3718 | EXPERIMENTAL | 1500 mg IW-3718 twice daily |
| IW-3718 | EXPERIMENTAL | Twice a day |
| Matching Placebo | PLACEBO_COMPARATOR | Twice a day |
| Name | Type | Description |
|---|---|---|
| IW-3718 | DRUG | oral tablet |
| placebo | DRUG | oral tablet |
| Standard-dose PPIs QD | DRUG | background therapy |
| Matching Placebo | DRUG | - |
| PPI | DRUG | All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium sesquihydrate, rabeprazole or rabeprazole sodium) during the study. |
Inclusion Criteria: Each patient must meet all of the following criteria to be eligible for enrollment in this study: * Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18 years old at the Screening Visit. * Patient has a diagnosis of GERD and reports experiencing G...
IW-3718 is an investigational small molecule being developed for gastroesophageal reflux disease (GERD), specifically for patients with persistent symptoms despite proton pump inhibitor (PPI) therapy. It has been studied in Phase 2 and Phase 3 clinical trials for this indication.
IW-3718 is being developed by Ironwood Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IRWD. The company has sponsored clinical trials of the drug in the United States and Canada.
IW-3718 has completed Phase 2 and Phase 3 clinical trials. The most advanced trial, NCT03561883, was a Phase 3 study. However, the drug remains investigational and has not been reported as approved by the FDA.
IW-3718 has been studied in three completed clinical trials: NCT02030925, a Phase 2a study in patients with gastroesophageal reflux not completely responsive to PPIs; NCT02637557, a Phase 2 trial in symptomatic GERD; and NCT03561883, a Phase 3 trial in persistent GERD.
No alternative names for IW-3718 have been reported. It is identified solely by its investigational code name IW-3718 in clinical trial records and by its developer, Ironwood Pharmaceuticals.