Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SPY001-001
SPY001 · 3 trials · 5 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.
Incidence, severity, and causal relationship of TEAEs
| 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 |
| SAD Cohorts 1-5 Experimental Arm | EXPERIMENTAL | Participants will receive a single dose of SPY001-001 in a dose escalation format |
| SAD Cohorts 1-5 Placebo Arm | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo |
| MAD Cohorts 1-2 Experimental Arm | EXPERIMENTAL | Participants will receive two doses of SPY001-001 in a dose escalation format |
| MAD Cohorts 1-2 Placebo Arm | PLACEBO_COMPARATOR | Participants will receive two doses of placebo |
| SAD Cohorts 6-7 Experimental Arm | EXPERIMENTAL | Participants of Japanese descent will receive a single dose of SPY001-001 |
| SAD Cohorts 6-7 Placebo Arm | PLACEBO_COMPARATOR | Participants of Japanese descent will receive a single dose of placebo |
| SAD Cohorts 8-9 Experimental Arm | EXPERIMENTAL | Participants of Chinese descent will receive a single dose of SPY001-001 |
| SAD Cohorts 8-9 Placebo Arm | PLACEBO_COMPARATOR | Participants of Chinese descent will receive a single dose of placebo |
| Name | Type | Description |
|---|---|---|
| SPY001 | DRUG | Experimental |
| SPY002 | DRUG | Experimental |
| SPY003 | DRUG | Experimental |
| Placebo | OTHER | Placebo |
| SPY001-001 | DRUG | Experimental |
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, ...
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SPY001 is an investigational small molecule being developed for ulcerative colitis, a form of inflammatory bowel disease. It is in Phase 2 clinical development and is being studied in adults with moderate to severe ulcerative colitis as well as in a broader inflammatory bowel disease study. It has not been approved for any use.
SPY001 targets the integrin α4β7, a cell surface receptor in the integrin class. By binding this integrin target, the drug is designed to interfere with the α4β7-mediated biology relevant to intestinal inflammation. Spyre Therapeutics is developing SPY001 as a small molecule for ulcerative colitis.
SPY001 is being developed by Spyre Therapeutics, Inc., which trades under the ticker SYRE. The company is advancing the small molecule through Phase 2 clinical testing in ulcerative colitis and related inflammatory bowel disease indications.
SPY001 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for ulcerative colitis or any other indication. Two Phase 2 trials are listed for SPY001, and both are currently active, with no completed trials reported.
SPY001 is being studied in two Phase 2 trials: NCT07012395, a recruiting study of long-acting antibodies alone and in combinations for moderate to severe ulcerative colitis, and NCT07652294, a long-term safety and efficacy study enrolling by invitation in inflammatory bowel disease. Both are randomized, double-blind, controlled trials with planned enrollment of 645 participants each.