Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HMPL-004 low dose · 1 trial · 1 indication
Clinical response at week 8, which is a decrease in the Mayo score from the baseline by ≥ 3 points AND ≥ 30% decrease in the Mayo score along with either a decrease in the rectal bleeding score ≥ 1 OR an absolute rectal bleeding score ≤ 1. The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome.
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | Matching dose of placebo will be given orally in capsules three times per day for 56 days. |
| HMPL-004 low dose | EXPERIMENTAL | A total of 1200 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days. |
| HMPL-004 high dose | EXPERIMENTAL | A total of 1800 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days. |
| Name | Type | Description |
|---|---|---|
| HMPL-004 low dose | DRUG | HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day). |
| Placebo | DRUG | Matching dose of Placebo |
| HMPL-004 high dose | DRUG | HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day). |
Inclusion Criteria: * Have active confirmed mild to moderate ulcerative colitis Exclusion Criteria: * Diagnosed with Crohn's Disease or
| 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 |
HMPL-004 low dose is an investigational small molecule being studied 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 specific molecular target of HMPL-004 low dose is not disclosed in available information. It is a small molecule therapeutic being evaluated for its effects on ulcerative colitis, but its mechanism of action has not been publicly detailed.
HMPL-004 low dose is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company is conducting clinical research on this asset for ulcerative colitis.
HMPL-004 low dose is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies and is still undergoing clinical trials to assess its safety and efficacy.
HMPL-004 low dose has one completed Phase 2 clinical trial registered under NCT00659802, titled 'Phase II Study of HMPL-004 in Patients With Ulcerative Colitis.' This randomized, double-blind, placebo-controlled trial enrolled 224 participants with ulcerative colitis.
HMPL-004 low dose is a specific dosage form of the drug candidate HMPL-004. The low dose refers to a particular strength being evaluated in clinical trials, while HMPL-004 may refer to the compound in general or other dose levels.