Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GED-0301 · 3 trials · 3 indications
Clinical remission was defined as a modified Mayo score of ≤ 2, with no individual subscore \> 1, at Week 8. The MMS was based on a modification of the total Mayo score (TMS) which included the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the Physician's Global Assessment (PGA) subscore, since this was a global measure that is subjective in nature. The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity. The endoscopy subscores was centrally reviewed. Two-sided confidence intervals for the within-group percentage were based on the Wilson score method.
Maximum observed concentration in plasma
Estimation of AUC from time zero extrapolated to infinity
The change from baseline in the Simplified Endoscopic Activity Score for Crohn's disease (SES-CD) score at Induction Week 12.
| Arm | Type | Description |
|---|---|---|
| GED-0301 160 mg once daily (QD) | EXPERIMENTAL | Patients will receive oral GED-0301 160 mg once daily (QD)for duration of 52 week treatment. |
| Treatment A = single oral dose GED 0301, fasted | EXPERIMENTAL | Subjects will receive a single oral 160 mg dose of GED-0301 after a 10 hour overnight fast |
| Treatment B = single oral dose GED 0301, fed | EXPERIMENTAL | Subjects will receive a single oral 160 mg dose of GED-0301 after a 10 hour overnight fast, and within 30 minutes of completely consuming a high fat meal. |
| Treatment C = single oral dose GED 0301 fasted | EXPERIMENTAL | Subjects will receive an oral dose of 160 mg of GED-0301 given as 4 tablets of 40 mg, after a 10 hour overnight fast |
| Treatment D = oral omeprazole and GED-0301 | EXPERIMENTAL | Subjects will receive one oral dose of 40 mg omeprazole once a day for 6 days. On the 5th day, a single oral 160 mg dose of GED-0301 will be given together with omeprazole. |
| GED-0301 160mg QD 12 WK | EXPERIMENTAL | GED-0301 160 mg once daily (QD) for 12 weeks |
| GED-0301 160 mg QD 8 WK | EXPERIMENTAL | GED-0301 160 mg QD for 8 weeks followed by 4 weeks of placebo |
| GED-0301 160 mg QD 4 WK | EXPERIMENTAL | GED-0301 160 mg QD for 4 weeks followed by 8 weeks of placebo |
| Name | Type | Description |
|---|---|---|
| GED-0301 | DRUG | - |
| Omeprazole | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: Inclusion Criteria: * Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Subject is able to understand and voluntarily sign an informed consent form (ICF)prior...
GED-0301 is an investigational small molecule being studied for gastrointestinal conditions, including Crohn's disease and ulcerative colitis. It has been evaluated in clinical trials for active Crohn's disease and active ulcerative colitis, and in healthy volunteers for pharmacokinetic studies. The drug is not approved and remains in clinical development.
GED-0301 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company has sponsored clinical trials of the drug in Crohn's disease, ulcerative colitis, and healthy volunteers.
GED-0301 is in Phase 2 clinical development. It has completed a Phase 2 trial in active ulcerative colitis and a Phase 1 trial in active Crohn's disease. The drug is investigational and has not been approved by regulatory authorities.
GED-0301 has been studied in three completed trials. NCT02367183 was a Phase 1 study in 64 subjects with active Crohn's disease. NCT02601300 was a Phase 2 study in 41 subjects with active ulcerative colitis. NCT02957474 was a Phase 1 study in 18 healthy volunteers.
Yes, GED-0301 is also known as Mongersen. The Phase 2 ulcerative colitis trial was titled 'An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis,' confirming that the two names refer to the same drug.