Spyre Therapeutics, Inc. recently announced the first patient has been dosed in its Phase 2 SKYWAY basket trial evaluating SPY072 in RA, PsA, and axSpA. SPY072 is an extended half-life investigational antibody targeting TL1A, a cytokine central to T-cell-driven inflammation. Designed for superior potency, convenience, and durability, SPY072 may set a new standard in the treatment of rheumatic diseases with its potential for quarterly or twice-yearly subcutaneous maintenance dosing.

“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,” said Josh Friedman, MD, PhD, SVP of Clinical Development at Spyre. “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.”

The SKYWAY Phase 2 trial is a randomized and placebo-controlled study evaluating SPY072 in patients with moderately to severely active RA, PsA, or axSpA with inadequate response to conventional or advanced therapies. Topline 12-week (RA) and 16-week (PsA, axSpA) proof-of-concept data are expected in 2026.

“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,” said Cameron Turtle, DPhil, Chief Executive Officer of Spyre. “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.”

SPY072 is an investigational, extended half-life monoclonal antibody targeting TL1A for the potential treatment of rheumatic diseases including rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Together, these conditions affect more than 3 million individuals in the United States. In head-to-head preclinical studies, SPY072 demonstrated potency equivalent to or better than first-generation anti-TL1As. Interim data from a Phase 1 trial demonstrated that SPY072 was well tolerated, exhibited prolonged pharmacokinetics, and rapidly and durably suppressed free TL1A. Based on Phase 1 clinical data, the Company is evaluating SPY072 in its SKYWAY-RD Phase 2 basket study (NCT07148414).

Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre’s pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. For more information, visit http://spyre.com.