Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Low Dose MT-1303 · 1 trial · 1 indication
The modified Mayo Score for ulcerative colitis disease activity provides an assessment of disease severity and can be used to monitor subjects during therapy. Scoring is accomplished by summation of subscores for endoscopic findings, stool frequency, and rectal bleeding, with higher scores indicating worse severity. Each subscore ranges from 0 to 3. The modified Mayo Score is defined as the sum of the endoscopy findings subscore + stool frequency subscore + rectal bleeding subscore, with a range from 0 to 9.
| Arm | Type | Description |
|---|---|---|
| Low Dose | EXPERIMENTAL | MT-1303 loading dose of 0.4 mg once daily (QD) (Day 1-14) then maintenance dose of 0.2 mg QD (Day 15-85) |
| High Dose | EXPERIMENTAL | MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85) |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, QD (Day 1-85) |
| Open Label Extension Period | OTHER | 0.4 mg MT-1303 QD for 36 weeks for those participants who continue on to the OLE period from the double-blind portion of the clinical study |
| Name | Type | Description |
|---|---|---|
| Low Dose MT-1303 | DRUG | MT-1303 loading dose of 0.4 mg once daily (QD) (Day 1-14) then maintenance dose of 0.2 mg QD (Day 15-85) |
| High Dose MT-1303 | DRUG | MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85) |
| Placebo | DRUG | Matching placebo, QD (Day 1-85) |
| MT-1303 | DRUG | 0.4 mg MT-1303 QD for 36 weeks for those participants who continue on to the OLE period from the double-blind portion of the clinical study |
Inclusion Criteria: * Subjects will be eligible if they are male or female aged between 18 to 75 years at time of consent (inclusive) with normal vital signs and a diagnosis of active mild ulcerative colitis (UC) (modified Mayo Score of 3 or 4) or moderate UC (modified Mayo Score of 5 to 8) confirm...
| 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 |
Low Dose MT-1303 is an investigational small molecule being developed for the treatment of ulcerative colitis, a chronic inflammatory bowel disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied for its efficacy and safety in patients with mild to moderate ulcerative colitis.
Low Dose MT-1303 is a small molecule that targets sphingosine 1-phosphate receptors, which play a role in immune cell trafficking. By modulating these receptors, the drug aims to reduce inflammation in the gastrointestinal tract. This mechanism is being evaluated in clinical trials for ulcerative colitis.
Low Dose MT-1303 is being developed by Bausch Health Companies Inc., a company traded on the stock exchange under the ticker symbol BHC. The drug is currently in Phase 2 clinical development for the treatment of ulcerative colitis.
Low Dose MT-1303 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for its safety and efficacy in patients with mild to moderate ulcerative colitis.
Low Dose MT-1303 has been studied in one completed Phase 2 clinical trial with the identifier NCT04857112. This trial evaluated the efficacy and safety of the drug in patients with mild to moderate ulcerative colitis. The study enrolled 322 participants and was conducted across multiple countries, including the United States, Japan, and several European nations.
Yes, Low Dose MT-1303 is also known as Amiselimod. The clinical trial NCT04857112, which evaluated the drug for ulcerative colitis, refers to it as Amiselimod (MT-1303). This alternative name is used in the study title and may be encountered in medical literature and trial registries.