Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Budesonide Multi-Matrix System
Budesonide MMX · 4 trials · 1 indication
Clinical remission defined as a score of 0 for rectal bleeding and 0 for stool frequency components from the Ulcerative Colitis Disease Activity Index (UCDAI). UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding were based on information recorded in daily participant diaries. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If either subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis. Participants who had clinical remission at Baseline were classified as non-responders.
Clinical remission was defined as the combined absence of recurrence of rectal bleeding and absence of increased stool frequency.
Clinical and endoscopic remission defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.
| Arm | Type | Description |
|---|---|---|
| Budesonide MMX | EXPERIMENTAL | Participants will receive 1 oral tablet of budesonide MMX 9 mg for 56 days. Additionally, participants will continue to receive the same dose of their existing oral 5-ASA medication from their treating physician. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 1 oral tablet of matching budesonide MMX placebo for 56 days. Additionally, participants will continue to receive the same dose of their existing oral 5-ASA medication from their treating physician. |
| 1: Budesonide MMX® 6 mg | EXPERIMENTAL | One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast. |
| 2: Placebo | PLACEBO_COMPARATOR | One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast. |
| 1: budesonide-MMX® 6 mg | EXPERIMENTAL | One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast. |
| 2: budesonide-MMX® 9 mg | EXPERIMENTAL | One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast. |
| 3: Entocort EC® 3 mg | ACTIVE_COMPARATOR | Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast. |
| 4: Placebo | PLACEBO_COMPARATOR | Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast. |
| 3: Placebo | PLACEBO_COMPARATOR | Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. |
| 4: Asacol® 400 mg | ACTIVE_COMPARATOR | Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. |
| Name | Type | Description |
|---|---|---|
| Budesonide MMX® | DRUG | Oral tablet taken daily in the morning after breakfast. |
| Placebo | DRUG | Matching budesonide MMX placebo oral tablet taken daily in the morning after breakfast. |
| 5-ASA | DRUG | Acceptable oral 5-ASA medications to be received during the study include: * Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g) * Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g * Dipentum® (generic: olsalazine), minimum daily dose ≥2.0 g * Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g |
| Budesonide MMX 6 mg Tablet | DRUG | Budesonide MMX 6 mg Tablet once daily. |
| Placebo Tablet | DRUG | Placebo Tablet once daily. |
| Blood sampling, endoscopy | PROCEDURE | Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores |
| Budesonide MMX® 6 mg | DRUG | 6 mg/day, 6 mg tablets |
| Budesonide MMX® 9 mg | DRUG | 9 mg/day, 9 mg tablets |
| Entocort EC® 3 mg | DRUG | 9 mg/day, 3 mg tablets |
| budesonide-MMX® 6 mg | DRUG | 6 mg/day, 6 mg tablets |
| budesonide-MMX® 9 mg | DRUG | 9 mg/day, 9 mg tablets |
| Asacol® 400 mg | DRUG | 2400 mg/day, 400 mg tablets |
Inclusion Criteria: 1. Age 18 to 75 years, inclusive. 2. Established diagnosis of UC, based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings. 3. Active mild or moderate UC with an ulcerative colitis disease activity index (UCDAI) score ≥4 an...
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Budesonide MMX is used for ulcerative colitis, a form of inflammatory bowel disease affecting the colon. It is a small molecule therapy developed by Bausch Health Companies Inc. (ticker BHC) and has been studied in Phase 3 clinical trials. The multi-matrix (MMX) formulation is designed to release budesonide in the colon.
Budesonide MMX targets NR3C1, the glucocorticoid receptor, and acts as an agonist at this receptor. By binding and activating NR3C1, budesonide produces local anti-inflammatory effects in the intestinal lining, which is the intended mechanism for treating ulcerative colitis.
Budesonide MMX is developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company has sponsored the clinical development program for this formulation in ulcerative colitis.
Budesonide MMX has been studied in Phase 3 clinical development for ulcerative colitis. Four Phase 3 trials have been completed, and no active trials are currently listed. The program enrolled a total of 1,657 participants across randomized, double-blind, placebo-controlled studies.
Budesonide MMX has been evaluated in four completed Phase 3 trials: NCT01532648, NCT00801723, NCT00679432, and NCT00679380. These randomized, double-blind, placebo-controlled studies enrolled adults with ulcerative colitis across North America, Europe, and other regions, with total enrollment of 1,657 participants.