Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Oral Budesonide Suspension (MB-9), Oral Budesonide Suspension (OBS)
Budesonide · 4 trials · 1 indication
Relapse (Yes/No) was defined as meeting both the eosinophil histology relapse criterion and the dysphagia symptom relapse criterion. Eosinophil histology relapse was defined as an eosinophil count of greater than or equal to(\> or =) 15 per high-power field (eos/hpf) from at least 2 of 3 levels of the esophagus. Dysphagia symptom relapse was defined as having at least 4 days of dysphagia (with answer 'Yes' for question 2 in DSQ \[Dysphagia Symptom Questionnaire\]) in the 2-week period prior to the scheduled visit, as determined by the DSQ.
Histologic response was defined as a peak eosinophil count of less than or equal to (\<=) 6/ high-powered field (HPF) across all available esophageal levels at final treatment period evaluation (Week 16). Histologic response after 12 weeks of double blind treatment at Week 16 was reported.
Dysphagia symptom response was defined as greater than or equal to (\>=) 30 percent (%) reduction in the Dysphagia Symptom Questionnaire (DSQ) combined score (questions 2+3). DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ score= (\[sum of points from questions 2+3 in the daily DSQ\]×14)/ Number of diaries reported with non-missing data. Dysphagia symptom response after 12 weeks of double blind treatment at Week 16 was reported.
Histologic response was defined as a peak eosinophil count \</= 6/high power field (light microscopy) (HPF) across all esophageal levels at the final treatment evaluation (Week 16). An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.
Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 \[14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data\]. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.
Response was defined as a ≥50% reduction from baseline in the eosinophilic esophagitis (EoE) clinical symptom score (CSS) and a reduction in peak eosinophil count to ≤6/high power field (light microscopy) from esophageal biopsies collected at the final evaluation. The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment: 0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on \>3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors.
| Arm | Type | Description |
|---|---|---|
| Arms A OBS Completers/ Responders | EXPERIMENTAL | Arm A Oral Budesonide Suspension Completers/ Responders |
| Arm B OBS Completers/ Responders | PLACEBO_COMPARATOR | Arm B Oral Budesonide Suspension Completers/ Responders. 1:1 randomization for Arms A and B |
| Arm C OBS Completers/ Non-Responders | EXPERIMENTAL | Arm C Oral Budesonide Suspension Completers/ Non-Responders |
| Arm D Placebo Completers | EXPERIMENTAL | Arm D Placebo Completers |
| Oral Budesonide Suspension (OBS) | EXPERIMENTAL | Participants will receive Oral Budesonide Suspension (OBS) 10 milliliter (ml) of 0.2 milligram per milliliter (mg/ml) twice daily up to 16 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive oral dose of 10 ml of placebo matched with the experimental drug twice daily up to 16 weeks. |
| Oral Budesonide Suspension | EXPERIMENTAL | Taken once or twice daily for up to 40 weeks |
| Matching Placebo | PLACEBO_COMPARATOR | Taken once or twice daily for 20 weeks |
| 1 | PLACEBO_COMPARATOR | - |
| 2 | EXPERIMENTAL | Low Dose Group |
| 3 | EXPERIMENTAL | Medium Dose Group |
| 4 | EXPERIMENTAL | High Dose Group |
| Name | Type | Description |
|---|---|---|
| Oral Budesonide Suspension (OBS) | DRUG | OBS 2mg twice daily |
| Placebo | DRUG | Matching Placebo dose |
| Oral Budesonide Suspension (MB-9) | DRUG | OBS suspension to be taken bid over a 16 week course of double blind therapy and OBS suspension to be taken qd to bid during a 24 week optional open label extension period |
| budesonide | DRUG | oral suspension |
Inclusion Criteria: 1. Subject completed SHP621-301 induction study. 2. Subject is able to provide written informed consent (subject, parent or legal guardian and, as appropriate, subject assent) to participate in the study before completing any study-related procedures. 3. Subject is male or femal...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tezepelumab |
| Regeneron Pharmaceuticals, Inc. | REGN | 3 | PHASE3 | dupilumab |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | PHASE2 | Vonoprazan |
| Eupraxia Pharmaceuticals, Inc. | EPRX | 1 | PHASE1 | EP-104GI |
| Sanofi SA Sponsored ADR | SNY | 1 | - | Dupilumab |
Budesonide is being developed as an oral suspension for eosinophilic esophagitis, a chronic inflammatory condition of the esophagus. The formulation is designed to deliver the drug directly to the esophageal lining in adults and adolescents. It is investigational for this indication and has completed Phase 3 clinical development.
Budesonide targets NR3C1, the glucocorticoid receptor, and acts as an agonist at this receptor. Binding to NR3C1 is the mechanism by which the drug produces its anti-inflammatory effects in the esophagus. This target class is well established for corticosteroid-based therapies.
Takeda Pharmaceutical Company Limited is developing the oral budesonide suspension for eosinophilic esophagitis. Takeda trades on the New York Stock Exchange under the ticker TAK. The company has sponsored the clinical program evaluating this formulation in adults and adolescents with the condition.
Budesonide oral suspension has completed Phase 3 development for eosinophilic esophagitis. Four trials in the program have finished, including two Phase 3 studies and two earlier Phase 2 studies. The program enrolled 712 participants in total across randomized, double-blind, placebo-controlled designs.
The budesonide oral suspension program includes NCT02736409, a Phase 3 extension study, and NCT02605837, a Phase 3 study measuring histologic response and dysphagia reduction. Earlier studies were NCT01642212, a Phase 2 trial with an open-label extension, and NCT00762073, a Phase 2 dose-ranging study in pediatric patients.
Yes. Budesonide oral suspension is also referred to as Oral Budesonide Suspension, or OBS, and as MB-9. These names describe the same investigational formulation developed by Takeda for eosinophilic esophagitis. Readers searching for OBS or MB-9 are looking at the same drug asset.