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Adjusted LOA
ML Risk
OD-07656 · 2 trials · 7 indications
The 3-component MMCS ranges from 0 to 9 and is composed of endoscopic assessment, rectal bleeding and stool frequency subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease.
reported SAEs and AEs
| Arm | Type | Description |
|---|---|---|
| OD-07656 Dosing Regimen 1 | EXPERIMENTAL | Open Label, Oral, twice daily dose |
| OD-07656 Dosing Regimen 2 | EXPERIMENTAL | Randomized, Oral, twice daily dose |
| OD-07656 Dosing Regimen 3 | EXPERIMENTAL | Randomized, Oral, twice daily dose |
| Part 1 - Single Ascending dose | EXPERIMENTAL | To assess the safety and tolerability of single ascending doses of OD-07656 administered as an oral capsule |
| Part 2 - Multiple Ascending dose | EXPERIMENTAL | To assess the safety and tolerability of multiple ascending doses of OD-07656 administered as an oral capsule |
| Part 3 - Food effect and relative bioavailability between dose forms | EXPERIMENTAL | To assess the safety and tolerability of OD-07656 administered as an oral capsule or tablet |
| Part 4 - Pharmacokinetic drug interaction between midazolam and OD-07656 | EXPERIMENTAL | To assess the safety and tolerability of OD-07656 administered as an oral capsule or tablet following administration of midazolam |
| Name | Type | Description |
|---|---|---|
| OD-07656 | DRUG | Experimental intervention |
| Vedolizumab | DRUG | Active standard of care comparator |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a confirmed diagnosis of ulcerative colitis (UC) * Has moderate to severely active UC as defined by the 3-component Modified Mayo clinic score * Has an inadequate response, loss of response, or into...
| 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 |
OD-07656 is an investigational small molecule being developed for inflammatory bowel diseases, including ulcerative colitis (UC). It is being studied in a Phase 2 trial for moderately to severely active ulcerative colitis, and a Phase 1 trial also included conditions such as Crohn disease, Blau syndrome, and spondyloarthritis.
OD-07656 targets RIPK2, a protein kinase involved in innate immune signaling. By inhibiting RIPK2, the drug is designed to modulate inflammatory pathways relevant to gastrointestinal diseases like ulcerative colitis.
OD-07656 is being developed by Odyssey Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials of the drug in patients with ulcerative colitis and related inflammatory conditions.
OD-07656 is in Phase 2 clinical development for moderately to severely active ulcerative colitis. A Phase 1 study in healthy participants has been completed, and the drug remains investigational and not yet approved by regulatory authorities.
OD-07656 has two clinical trials. NCT06206811 is a completed Phase 1 study in healthy adult participants in Australia. NCT06850727 is a recruiting Phase 2 trial evaluating safety and efficacy of OD-07656 and subsequent vedolizumab therapy in moderately to severely active ulcerative colitis across multiple countries.
OD-07656 is the sole name provided for this investigational drug. No alternative names or brand names have been associated with it in the available clinical trial information.