Our pipeline of novel antibodies targets validated mechanisms with the potential to treat several gastrointestinal and rheumatological conditions
Our Pipeline
Trial
Indication
Program
Target
Phase 1
Phase 2
Phase 3
Status
UC
SPY001
α4β7
Ph2 initiated
SPY002
TL1A
Ph2 initiation expected Q3 2025
SPY003
IL-23
Ph2 initiation expected after Ph1 interim (2H 2025)
SPY120
α4β7 + TL1A
Ph2 initiation expected after Part A (mono open-label)
SPY130
α4β7 + IL-23
Ph2 initiation expected after Part A (mono open-label)
SPY230
IL-23 + TL1A
Ph2 initiation expected after Part A (mono open-label)
RA
Ph2 initiation expected Q3 2025
PsA
SPY072
TL1A
Ph2 initiation expected Q3 2025
axSpA
Ph2 initiation expected Q3 2025
Indication:
UC
SPY001
α4β7
Ph2 initiated
Indication:
UC
SPY002
TL1A
Ph2 initiating Q3 2025
Indication:
UC
SPY003
IL-23
Ph2 initiating after Ph1 interim
Indication:
UC
SPY120
α4β7 + TL1A
Ph2 initiation expected after Part A (mono open-label)
Indication:
UC
SPY130
α4β7 + IL-23
Ph2 initiation expected after Part A (mono open-label)
Indication:
UC
SPY230
IL-23 + TL1A
Ph2 initiation expected after Part A (mono open-label)
Indication:
RA
SPY072
TL1A
Ph2 initiating Q3 2025
Indication:
RA
PsA
TL1A
Ph2 initiating Q3 2025
Indication:
RA
axSpA
TL1A
Ph2 initiating Q3 2025
Our programs
SPY001
SPY001 is a novel, half-life extended monoclonal antibody targeting α4β7 for the potential treatment of IBD
In head-to-head preclinical studies, SPY001 demonstrated similar potency and selectivity as vedolizumab
In interim results for a Phase 1 clinical study, SPY001 was well tolerated and exhibited a half-life of more than 3-times that of vedolizumab, supporting the potential for quarterly or biannual chronic dosing based on population PK modeling
SPY001 is being evaluated in the Phase 2 SKYLINE-UC trial in UC patients
SPY002
SPY002 is a novel, half-life extended monoclonal antibody targeting TL1A for the potential treatment of IBD
In head-to-head preclinical studies, SPY002 exhibited comparable or superior potency to first-generation anti-TL1As
In interim results for a Phase 1 clinical study, SPY002 was well tolerated and exhibited a half-life more than 3-times that of first-generation anti-TL1As, supporting the potential for quarterly or biannual chronic dosing based on population PK modeling
Spyre plans to evaluate SPY002 in the Phase 2 SKYLINE-UC trial in UC patients after Phase 1 interim results
SPY003
SPY003 is a novel, half-life extended monoclonal antibody targeting IL-23 for the potential treatment of IBD
In head-to-head preclinical studies, SPY003 exhibited comparable potency to risankizumab
In non-human primates, SPY003 exhibited a half-life more than 3-times that of risankizumab, supporting the potential for quarterly or biannual chronic dosing based on PK modeling. A Phase 1 clinical study of SPY003 is ongoing
Spyre plans to evaluate SPY003 in the Phase 2 SKYLINE-UC trial in UC patients after Phase 1 interim results
SPY120
SPY120 is a combination of SPY001 (anti-α4β7) and SPY002 (anti-TL1A) for the potential treatment of IBD
In preclinical models of colitis, combined inhibition of α4β7 and TL1A resulted in superior efficacy compared to either monotherapy alone
High-concentration coformulation data support potential for delivery in a single injector with chronic administration on a quarterly or biannual basis.
Spyre plans to evaluate SPY120 in Part B of the Ph2 SKYLINE-UC trial after
completion of Part A of the study
completion of Part A of the study
SPY130
SPY130 is a combination of SPY001 (anti-α4β7) and SPY003 (anti-IL-23) for the potential treatment of IBD
In preclinical models of colitis, combined inhibition of α4β7 and IL-23 resulted in additive efficacy of either monotherapy alone
High-concentration coformulation data support potential for delivery in a single injector with chronic administration on a quarterly or biannual basis.
Spyre plans to evaluate SPY130 in Part B of the Ph2 SKYLINE-UC trial after
completion of Part A of the study
completion of Part A of the study
SPY230
SPY230 is a combination of SPY002 (anti-TL1A) and SPY003 (anti-IL-23) for the potential treatment of IBD
In preclinical models of colitis, combined inhibition of TL1A and IL-23 resulted in additive efficacy of either monotherapy alone
High-concentration coformulation data support potential for delivery in a single injector with chronic administration on a quarterly or biannual basis.
Spyre plans to evaluate SPY230 in Part B of the Ph2 SKYLINE-UC trial after
completion of Part A of the study
completion of Part A of the study
SPY072
SPY072 is a novel, half-life extended monoclonal antibody targeting TL1A for the potential treatment of rheumatic diseases including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA)
SPY072 is a distinct anti-TL1A molecule from SPY002, which is being studied in IBD
Spyre plans to evaluate SPY072 in the Ph2 SKYWAY-RD trial in RA, PsA, and axSpA, pending regulatory feedback
Product candidates discussed are investigational and currently being studied in clinical trials. Their safety and efficacy have not been established and they have not been approved for any use by FDA, the European Commission, or any other health authority.
