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 oral small molecule developed for gastroesophageal reflux disease, or GERD. It is being studied in patients whose reflux symptoms persist despite treatment with proton pump inhibitors. It has not been approved for any indication and remains in clinical development.
IW-3718 is being developed by Ironwood Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker IRWD. Ironwood is a gastrointestinal-focused biopharmaceutical company, and IW-3718 is part of its pipeline of reflux-related therapies.
IW-3718 has completed Phase 2 and Phase 3 clinical trials in gastroesophageal reflux disease. The Phase 3 study NCT03561883 and the Phase 2 study NCT02637557 have both been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA.
IW-3718 has been evaluated in three completed randomized, double-blind, placebo-controlled trials: NCT03561883, a Phase 3 trial in 609 patients with persistent GERD on proton pump inhibitors; NCT02637557, a Phase 2 trial in 282 patients with symptomatic GERD; and NCT02030925, a Phase 2a trial in 93 patients with reflux not fully responsive to proton pump inhibitors.
No. IW-3718 is an investigational drug and has not been approved by the FDA for any indication. It has completed Phase 2 and Phase 3 clinical development in gastroesophageal reflux disease, and no clinical trials of IW-3718 are currently active.