Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPY001 · 2 trials · 4 indications
Incidence of treatment-emergent adverse events (TEAEs) as measured over time.
Change in Robarts Histopathology Index (RHI) from baseline at Week 12 will be assessed. The RHI is used to quantify and assess histological activity of UC, comprising of scores for inflammatory infiltrates, neutrophils, erosions or ulceration. Scores are assigned to each of these features, with a total ranging from 0 (no disease activity) to 33 (most severe disease activity). Higher score indicates more severe disease.
Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is based on the modified Mayo subscores, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.
| Arm | Type | Description |
|---|---|---|
| SPY001 Dosing Regimen 1 | EXPERIMENTAL | Participants will receive SPY001 |
| SPY002 Dosing Regimen 1 | EXPERIMENTAL | Participants will receive SPY002 |
| SPY003 Dosing Regimen 1 | EXPERIMENTAL | Participants will receive SPY003 |
| SPY001 Dosing Regimen 2 | EXPERIMENTAL | Participants will receive SPY001 |
| SPY002 Dosing Regimen 2 | EXPERIMENTAL | Participants will receive SPY002 |
| SPY003 Dosing Regimen 2 | EXPERIMENTAL | Participants will receive SPY003 |
| SPY001 & SPY002 | EXPERIMENTAL | Participants will receive SPY001 and SPY002 |
| SPY001 & SPY003 | EXPERIMENTAL | Participants will receive SPY001 and SPY003 |
| SPY002 & SPY003 | EXPERIMENTAL | Participants will receive SPY002 and SPY003 |
| SPY002 Dosing Regimen 3 | EXPERIMENTAL | Participants will receive SPY002 |
| Intervention Specific Appendix - SPY001: Part A | EXPERIMENTAL | Participants will receive open-label dose of SPY001 |
| Intervention Specific Appendix - SPY002: Part A | EXPERIMENTAL | Participants will receive open-label dose of SPY002 |
| Intervention Specific Appendix - SPY003: Part A | EXPERIMENTAL | Participants will receive open-label dose of SPY003 |
| Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B | EXPERIMENTAL | Participants will receive double-blind dosing regimen 1 of SPY001 |
| Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B | EXPERIMENTAL | Participants will receive double-blind dosing regimen 2 of SPY001 |
| Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B | EXPERIMENTAL | Participants will receive double-blind dosing regimen 1 of SPY002 |
| Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part B | EXPERIMENTAL | Participants will receive double-blind dosing regimen 2 of SPY002 |
| Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part B | EXPERIMENTAL | Participants will receive double-blind dosing regimen 1 of SPY003 |
| Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part B | EXPERIMENTAL | Participants will receive double-blind dosing regimen 2 of SPY003 |
| Intervention Specific Appendix - SPY120: Part B | EXPERIMENTAL | Participants will receive double-blind dose of SPY001 and SPY002 |
| Intervention Specific Appendix - SPY130: Part B | EXPERIMENTAL | Participants will receive double-blind dose of SPY001 and SPY003 |
| Intervention Specific Appendix - SPY230: Part B | EXPERIMENTAL | Participants will receive double-blind dose of SPY002 and SPY003 |
| Placebo: Part B | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| Name | Type | Description |
|---|---|---|
| SPY001 | DRUG | Experimental |
| SPY002 | DRUG | Experimental |
| SPY003 | DRUG | Experimental |
| Placebo | OTHER | Placebo |
Inclusion Criteria: Participants must meet 1 of the following criteria from Study SPY123-201: 1. Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator 2. Completed Part B 3. Participated in Part B and met escape criteria per the SPY123-201 protocol (ie, ...
| 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 | 11 | 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 |