Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HMPL-004 · 1 trial · 1 indication
Percentage of subjects with CDAI clinical response -100 at Week 8 based on ITT population using the WOCF method to impute missing CDAI scores at Week 8. Clinical response -100 was defined as CDAI score decrease of ≥100 points from baseline in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8. The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome.
| Arm | Type | Description |
|---|---|---|
| HMPL-004 | EXPERIMENTAL | Subjects who fulfilled all entry criteria and randomized HMPL-004 arm will receive HMPL-004 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up. |
| Placebo | PLACEBO_COMPARATOR | Subjects who fulfilled all entry criteria and randomized Placebo arm will receive matching placebo 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up. |
| Name | Type | Description |
|---|---|---|
| HMPL-004 | DRUG | HMPL-004 1200 mg/d |
| Placebo | DRUG | Placebo 1200 mg/d |
Inclusion Criteria: * Have active confirmed Crohn's Disease (confirmed radiographically, endoscopic, or histologically), with a CDAI of 220-400 at baseline screen Exclusion Criteria: * They have received anti-TNF-α antibody within 3 months of starting study medication, or cyclosporine, tacrolimus...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Risankizumab On-Body Injector |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
HMPL-004 is an investigational small molecule being studied for the treatment of Crohn's Disease, a type of inflammatory bowel disease. It is being developed by HUTCHMED (China) Limited and has completed a Phase 2 clinical trial to evaluate its safety and efficacy in patients with this condition.
HMPL-004 is a small molecule, but its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential therapeutic effects in Crohn's Disease, though the exact mechanism of action is not publicly detailed.
HMPL-004 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 drug candidate for the treatment of Crohn's Disease.
HMPL-004 is in Phase 2 of clinical development. It has completed a Phase 2 clinical trial for Crohn's Disease, and the drug remains investigational, meaning it has not yet been approved by regulatory authorities for commercial use.
HMPL-004 has been studied in one completed clinical trial, identified as NCT00655733, titled 'Phase II Study of HMPL-004 in Subjects With Crohn's Disease'. This trial enrolled 101 participants and was a randomized, double-blind, placebo-controlled study.
HMPL-004 is a unique drug candidate and no alternative names have been reported in available information. It is being developed specifically by HUTCHMED (China) Limited for Crohn's Disease and is not known to be identical to any other marketed or investigational drug.