Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
5-ASA · 2 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.
| 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. |
| 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 |
| 5 ASA, enemas, suppositories, corticosteroids | DRUG | - |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 10 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Upadacitinib |
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Tulisokibart |
| Pfizer Inc. | PFE | 8 | PHASE3 | Etrasimod |
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Filgotinib |
| Abivax SA Sponsored ADR | ABVX | 2 | PHASE3 | ABX464 |
| Bristol-Myers Squibb Company | BMY | 5 | PHASE2 | Ozanimod |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| AnaptysBio, Inc. | ANAB | 1 | PHASE2 | Rosnilimab |
| Palatin Technologies, Inc. | PTN | 1 | PHASE2 | PL8177 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4528287 |
| Xencor, Inc. | XNCR | 1 | PHASE1 | XmAb942 |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE2 | 627 |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
5-ASA is a small molecule used for the treatment of Ulcerative Colitis, a type of inflammatory bowel disease. It is being investigated in Phase 3 clinical trials for this condition. The drug is developed by Bausch Health Companies Inc. and is intended to manage symptoms associated with mildly to moderately active Ulcerative Colitis.
5-ASA, also known as mesalamine or 5-aminosalicylic acid, is an anti-inflammatory agent that works locally in the gastrointestinal tract. It is thought to reduce inflammation in the colon by inhibiting the production of pro-inflammatory chemicals. However, the specific molecular target has not been disclosed in the available information.
5-ASA is developed by Bausch Health Companies Inc., a company listed on the stock exchange under the ticker symbol BHC. The drug is being studied for the treatment of Ulcerative Colitis and is currently in Phase 3 clinical development.
5-ASA is in Phase 3 clinical development for the treatment of Ulcerative Colitis. It is an investigational drug and has not yet been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total enrollment of 735 participants, but the drug is still undergoing clinical evaluation.
5-ASA has been studied in two completed Phase 3 clinical trials. The first trial, NCT00269438, evaluated a new tablet formulation and dosing regimen of balsalazide disodium in patients with mildly to moderately active Ulcerative Colitis, enrolling 225 participants in the United States. The second trial, NCT01532648, assessed budesonide MMX in patients with Ulcerative Colitis currently on 5-ASA, enrolling 510 participants across multiple countries.
5-ASA, or 5-aminosalicylic acid, is the active moiety of balsalazide disodium, a prodrug that releases 5-ASA in the colon. In the clinical trial NCT00269438, balsalazide disodium was studied as a new tablet formulation and dosing regimen for Ulcerative Colitis. Therefore, while they are related, they are not the same compound.