Spyre Therapeutics Doses First Patient In Phase 2 SKYWAY Basket Trial Of SPY072, The First Anti-TL1A Antibody Studied In Rheumatic Diseases

Spyre Therapeutics, Inc., a clinical-stage biotechnology company focused on developing advanced antibody therapies and optimized treatment strategies for immune-mediated diseases, has announced that the first patient has been dosed in its Phase 2 SKYWAY basket trial. This study is evaluating SPY072 for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA).

SPY072 is an investigational antibody engineered with an extended half-life and designed to target TL1A, a cytokine that plays a key role in T-cell-driven inflammation. With its high potency, convenience, and long-lasting effects, SPY072 has the potential to improve the standard of care for rheumatic diseases by offering maintenance dosing just four times a year or even twice a year through subcutaneous administration.

Josh Friedman, M.D., Ph.D., SVP of Clinical Development at Spyre, stated, “RA, PsA, and axSpA collectively affect millions of patients globally, including more than three million in the U.S., yet the vast majority do not achieve durable remission with today’s therapies and require frequent injections or infusions. 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.”

Cameron Turtle, DPhil, Chief Executive Officer of Spyre, mentioned, “We are excited that Spyre is pioneering a potential new therapeutic class for rheumatic diseases. SKYWAY is our second Phase 2 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 totaling over $60B in annual revenue.”

The SKYWAY Phase 2 trial is a randomized, placebo-controlled study enrolling patients with moderately to severely active RA, PsA, or axSpA who have not responded adequately to conventional or advanced therapies. The trial aims to assess the safety and effectiveness of SPY072 across these three conditions. Topline proof-of-concept data are expected in 2026, with results anticipated at 12 weeks for rheumatoid arthritis and at 16 weeks for psoriatic arthritis and axial spondyloarthritis. Spyre Therapeutics believes that SPY072, through its innovative design and extended dosing intervals, could represent a meaningful advancement in treating inflammatory and rheumatic diseases.