Spyre Therapeutics has initiated dosing in its randomised Phase II SKYWAY basket trial of SPY072 in treating three rheumatic conditions: psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), and rheumatoid arthritis (RA).
The placebo-controlled study aims to assess the impact of SPY072 on patients suffering from moderate to severe RA, axSpA, or PsA, who have not adequately responded to traditional or advanced treatments.
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The company anticipates the release of topline 12-week data for RA and 16-week data for PsA and axSpA in 2026, which will serve as the proof-of-concept for the trial.
Spyre Therapeutics CEO Cameron Turtle said: “We are excited that Spyre is pioneering a potential new therapeutic class for rheumatic diseases. SKYWAY is our second Phase II trial launch this year, alongside the SKYLINE study evaluating three monotherapies and three combinations in IBD patients.
“Together, we expect these two trials to deliver nine placebo-controlled proof-of-concept readouts over the next two years. These trials aim to efficiently identify multiple products with indication-leading profiles in commercial markets totalling over $60bn in annual revenue.”
SPY072 is said to be an extended half-life monoclonal antibody that targets TL1A.
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By GlobalDataA Phase I study’s interim data indicated that SPY072 was tolerated well, had extended pharmacokinetics, and reduced free TL1A levels.
These findings have led to the assessment of SPY072 in the Phase II SKYWAY-RD basket study.
Spyre Therapeutics clinical development senior vice-president Josh Friedman said: “The evidence for TL1A inhibition in these conditions spans human genetics, in vitro studies, and animal models, suggesting that SPY072 has the potential to match or exceed the efficacy of current therapeutics.
“With a target dosing profile superior to any existing therapy in these indications, SPY072 has the potential to become a first- and best-in-class therapy for rheumatic diseases.”
Spyre is focused on developing treatments for inflammatory bowel disease (IBD) and other immune-mediated diseases by leveraging antibody engineering, dose optimisation, and strategic therapeutic combinations.
Last year, Spyre dosed the first subjects in the Phase I trial of SPY001 to potentially treat IBD.
