Spyre Therapeutics Completes Recruitment For RA Sub-Study Of SKYWAY Trial Ahead Of Schedule

Spyre Therapeutics, Inc., a clinical-stage biotechnology company focused on developing long-acting antibodies and antibody combinations for the treatment of inflammatory bowel disease (IBD) and rheumatic diseases, announced the completion of recruitment for the rheumatoid arthritis (RA) sub-study of its SKYWAY basket trial. The company also shared that the expected topline readout for this study has been accelerated to the third quarter of 2026.

Joshua Friedman, M.D., Ph.D., Senior Vice President of Clinical Development and lead investigator of the SKYWAY study, stated that enrollment in the RA sub-study exceeded expectations. He highlighted that this achievement reflects both the substantial unmet medical need in RA and the enthusiasm of investigators for the potential of a long-acting anti-TL1A antibody. Dr. Friedman noted that the upcoming proof-of-concept data, expected in the third quarter, could support advancement to pivotal trials next year. Along with readouts from the SKYLINE study, Spyre anticipates generating important data from its programs in IBD and rheumatic diseases in every subsequent quarter this year.

The SKYWAY Phase 2 trial (NCT07148414) is a randomized, placebo-controlled study evaluating SPY072 in patients with moderately to severely active RA, psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) who have shown inadequate response to conventional or advanced therapies. Topline proof-of-concept results are expected in the third quarter for RA, with results for PsA and axSpA anticipated in the fourth quarter.

SPY072 is an investigational antibody with an extended half-life that targets TL1A, a cytokine central to T-cell-driven inflammation. The therapy is designed to provide superior potency and durability, with the potential for subcutaneous maintenance dosing once every three or six months. If successful, SPY072 could offer a new standard of care in rheumatic diseases by improving convenience and treatment outcomes for patients.

Spyre Therapeutics continues to focus on advancing its pipeline of long-acting investigational antibodies, including candidates targeting α4β7, TL1A, and IL-23, with the goal of redefining treatment standards in both inflammatory bowel disease and rheumatic disorders.