Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SPY001
SPY001-001 · 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, ...
SPY001-001 is an investigational small molecule developed by Spyre Therapeutics, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed, so its therapeutic use is not publicly defined.
SPY001-001 is being developed by Spyre Therapeutics, Inc., which trades on the Nasdaq under the ticker SYRE. The company sponsored the Phase 1 study of the compound in healthy volunteers.
SPY001-001 is in Phase 1 development. One Phase 1 trial, NCT06448247, has been completed. The drug is investigational and is not approved by the FDA for any indication.
SPY001-001 has been evaluated in one Phase 1 trial, NCT06448247, titled A Study of SPY001-001 in Healthy Volunteers. The trial enrolled 96 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States and Canada. It is listed as completed.
The Phase 1 trial NCT06448247 enrolled 96 healthy adult volunteers aged 18 years and older, with no restriction by sex. Participants were recruited in the United States and Canada. The study used a randomized, double-blind, placebo-controlled design.