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Get filing alertsSpyre's SPY002 meets Phase 2 endpoint in ulcerative colitis with 10.7-point disease reduction
Filed June 15, 2026 · Period ending June 15, 2026 · ~1 min read
Key Changes
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SPY002 achieved primary endpoint with statistically significant 10.7-point reduction in disease severity score (p<0.0001), plus 33% clinical remission and 42% endoscopic improvement rates in 48-patient trial
Item 8.01 — Other Events verify on EDGAR → -
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Drug was well tolerated with only 2 serious adverse events (both deemed unrelated to treatment), 41.7% overall adverse event rate, and 4.2% discontinuation rate
Item 8.01 — Other Events verify on EDGAR → -
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Company initiated Part B enrollment evaluating combination therapies and remains on track for SPY003 (anti-IL-23) Phase 2 data in Q3 2026
Exhibit 99.1 view on EDGAR → -
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Phase 2 results delivered within one year of Phase 1 completion, demonstrating rapid clinical development execution with multiple additional readouts expected in 2026
Exhibit 99.1 view on EDGAR →
Summary
Spyre announced positive Phase 2 results for SPY002, its investigational antibody targeting TL1A, in moderate-to-severe ulcerative colitis. The 48-patient SKYLINE trial met its primary endpoint with a statistically significant 10.7-point reduction in Robarts Histopathology Index score at 12 weeks (p<0.0001), alongside secondary endpoints showing 33% clinical remission and 42% endoscopic improvement.
The company characterized these efficacy results as among the highest reported in UC. The safety profile was favorable, with only two serious adverse events (both deemed unrelated to the drug) and a 4.2% discontinuation rate. The trial enrolled patients with mean disease duration of 7.0 years, 35% of whom had prior advanced therapy exposure, suggesting the drug may work in treatment-experienced populations.
Spyre has begun enrolling Part B of SKYLINE to evaluate combination therapies and expects SPY003 anti-IL-23 data in Q3 2026. For a clinical-stage biotech, successful Phase 2 data represents meaningful validation of the drug candidate and de-risks the path to pivotal trials, though regulatory approval and commercial success remain years away.
Section-by-Section Diff
Event · Exhibit 99.1
Spyre announced positive Phase 2 trial results for SPY002 in ulcerative colitis, meeting primary endpoint with 10.7-point RHI reduction.
Added in current filing · view on EDGAR →
SPY002 met its primary endpoint with a statistically significant reduction of 10.7 points (p<0.0001) from baseline at Week 12 in Robart’s Histopathology Index (RHI) score
Spyre's SPY002 antibody targeting TL1A achieved its primary endpoint in a Phase 2 trial for moderate-to-severe ulcerative colitis, showing a statistically significant 10.7-point reduction in disease severity. Secondary endpoints included 33% clinical remission and 42% endoscopic improvement rates. The trial enrolled 48 patients with mean disease duration of 7.0 years, 35% of whom had prior advanced therapy exposure.
Added in current filing · verify on EDGAR →
SPY002 was well tolerated with a safety profile consistent with the TL1A class. There were twenty subjects with treatment-emergent adverse events (TEAEs) during the induction treatment period. Two serious adverse events (SAEs) were reported, both deemed not drug-related. One case was for hospitalization for exacerbation of UC, the other case was for worsening of heart failure in a subject with a history of heart failure.
The drug showed a favorable safety profile with 41.7% of patients experiencing adverse events, only two serious adverse events (both deemed unrelated to the drug), and no drug-related serious adverse events or deaths. The most common adverse events were arthralgia, hypertension, nausea, UC, and viral respiratory tract infection, each occurring in 2-3 patients.
Added in current filing · view on EDGAR →
We are now enrolling Part B of the SKYLINE trial, which includes three combination arms with the potential to deliver best-in-disease efficacy, safety, and treatment experience.
Spyre has initiated enrollment in Part B of the SKYLINE trial, which will evaluate combination therapies alongside monotherapies in a randomized, placebo-controlled design. The company remains on track to report Part A data for SPY003 (anti-IL-23) in Q3 2026, which would complete proof-of-concept for all investigational monotherapy components.
Event · Item 7.01 — Regulation FD Disclosure
Spyre announced positive 12-week Phase 2 trial results for SPY002 in ulcerative colitis treatment.
Added in current filing · verify on EDGAR →
On June 15, 2026, Spyre Therapeutics, Inc. (“Spyre” or the “Company”) issued a press release announcing positive initial 12-week induction topline data from Part A of the Phase 2 SKYLINE trial of SPY002 for the treatment of moderately-to-severely active ulcerative colitis (“UC”).
Spyre disclosed positive topline results from the first 12 weeks of its Phase 2 SKYLINE trial evaluating SPY002 as a treatment for moderately-to-severely active ulcerative colitis. The company characterized the initial induction data as positive, though specific efficacy metrics and safety data are not detailed in the 8-K itself.
Event · Item 8.01 — Other Events
Spyre announced positive Phase 2 trial results for SPY002 in ulcerative colitis, meeting primary endpoint with statistically significant improvement.
Added in current filing · verify on EDGAR →
On June 15, 2026, the Company announced positive initial 12-week induction topline data from Part A of the Phase 2 SKYLINE trial of SPY002 for the treatment of moderately-to-severely active UC.
Spyre disclosed positive 12-week results from the SKYLINE Phase 2 trial of SPY002, an investigational treatment for moderately-to-severely active ulcerative colitis. This is a key clinical milestone for the company's lead drug candidate.
Added in current filing · verify on EDGAR →
SPY002 was well tolerated with a safety profile consistent with the TL1A class. There were twenty subjects with treatment-emergent adverse events (“TEAEs”) during the induction treatment period. Two serious adverse events (“SAEs”) were reported, both deemed not drug-related.
The drug was well tolerated with 20 of 48 subjects (41.7%) experiencing adverse events. Two serious adverse events occurred but were deemed not drug-related: one UC exacerbation requiring hospitalization and one worsening heart failure in a patient with pre-existing heart condition. Only 3 subjects (6.3%) had drug-related adverse events, and 2 subjects (4.2%) discontinued due to adverse events.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jun 21, 2026 · How we verify