Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SPY002-072
SPY072 · 2 trials · 9 indications
HiSCR75 is defined as at least a 75% reduction from baseline in total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining tunnel count
The score is calculated based on the number of tender and swollen joints out of 28 assessed (TJC28 and SJC28), a measure of inflammation in the blood (c-reactive protein, CRP), and the subject's overall assessment of their health (patient global assessment). Scores range from 0-10. Higher scores indicate greater disease activity.
The score combines 5 disease activity variables (back pain, duration of morning stiffness, patient global assessment of disease activity, peripheral pain/swelling and measure of inflammation) to measure disease activity. Lowest score is 0.6 and increases as disease worsens. Higher scores indicate greater disease activity.
The proportion of subjects who achieve at least 20% improvement in tender and swollen joint counts (TJC and SJC), and at least 20% improvement in 3 out of 5 other disease activity measures (patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire, and measure of inflammation) will be assessed.
| Arm | Type | Description |
|---|---|---|
| SPY072 + bimekizumab | EXPERIMENTAL | Participants receive SPY072 + bimekizumab |
| Placebo + bimekizumab | PLACEBO_COMPARATOR | Participants receive matching placebo for SPY072 + bimekizumab |
| Rheumatoid Arthritis, Dose Regimen 1 | EXPERIMENTAL | Participants will receive double-blind dosing regimen 1 of SPY072 |
| Rheumatoid Arthritis, Dose Regimen 2 | EXPERIMENTAL | Participants will receive double-blind dosing regimen 2 of SPY072 |
| Psoriatic Arthritis | EXPERIMENTAL | Participants will receive double-blind dose of SPY072 |
| Axial Spondyloarthritis | EXPERIMENTAL | Participants will receive double-blind dose of SPY072 |
| Rhematoid Arthritis Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| Psoriatic Arthritis Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| Axial Spondyloarthritis Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| Name | Type | Description |
|---|---|---|
| SPY072 | DRUG | Solution for SC injection |
| Placebo | DRUG | Matching placebo for SC injection |
| bimekizumab | DRUG | Advanced standard of care |
| SPY002-072 | DRUG | Experimental |
Inclusion Criteria: * Clinical diagnosis of Hidradenitis Suppurativa with symptoms for at least 6 months before screening. * Hidradenitis suppurativa lesions in at least 2 distinct anatomical areas, with at least 1 area meeting Hurley Stage II or III criteria at screening and Day 1. * Total abscess...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Upadacitinib, Lutikizumab |
| Incyte Corporation | INCY | 6 | PHASE3 | povorcitinib, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Remibrutinib, Secukinumab |
| Sanofi SA Sponsored ADR | SNY | 3 | PHASE2 | Duvakitug, Brivekimig, SAR445399 |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Zura Bio Limited Class A | ZURA | 1 | PHASE2 | Tibulizumab |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | Olatorepatide |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY072 |
| Oruka Therapeutics, Inc. | ORKA | 1 | PHASE2 | ORKA-002 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE1 | SAR447971 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE1 | Soquelitinib |
SPY072 is an investigational small molecule being developed for the treatment of moderate to severe Hidradenitis Suppurativa (HS), a chronic inflammatory skin condition. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
SPY072 targets TL1A, a protein involved in inflammatory signaling pathways. By modulating this target, SPY072 is being studied as a potential therapy for Hidradenitis Suppurativa, though its exact mechanism of action is still under investigation in clinical trials.
SPY072 is being developed by Spyre Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker SYRE. The company is conducting clinical trials to evaluate the safety and efficacy of SPY072 in patients with Hidradenitis Suppurativa.
SPY072 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received approval from regulatory agencies such as the FDA. The ongoing Phase 2 trial is designed to assess its effects in adults with moderate to severe Hidradenitis Suppurativa.
SPY072 is being evaluated in a Phase 2 clinical trial with the identifier NCT07766005, known as the SKYLIGHT Trial. This randomized, double-blind, placebo-controlled study is enrolling approximately 150 adults with moderate to severe Hidradenitis Suppurativa in the United States. The trial is not yet recruiting participants.