Spyre Therapeutics Announces Completion of Enrollment in SKYWAY Basket Trial Evaluating SPY072 (anti-TL1A) in RA, PsA, and axSpA

Enrollment for psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) sub-studies of the SKYWAY basket trial are complete

Company reiterates expected Q3 2026 readout for rheumatoid arthritis (RA) and Q4 2026 readouts for PsA and axSpA

Across SKYWAY and SKYLINE trials, planned ‘6 in '26' Phase 2 readouts enabled and on track

Preclinical data supporting SPY072 in rheumatic diseases presented at 2026 European Congress of Rheumatology (EULAR)

WALTHAM, Mass., June 03, 2026 (GLOBE NEWSWIRE) -- Spyre Therapeutics, Inc. (NASDAQ:SYRE), a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients, today announced the completion of enrollment for all sub-studies in the SKYWAY basket trial of SPY072 (anti-TL1A) in rheumatic diseases.

"Completing enrollment across all SKYWAY sub-studies in less than nine months underscores the substantial unmet need among the more than three million U.S. patients living with RA, PsA, and axSpA and high enthusiasm for SPY072 as a potential first- and best-in-class anti-TL1A therapy in rheumatic diseases," said MiRa Huyghe, SVP of Development Operations. "This pace of execution further demonstrates our ability to deliver results on or ahead of schedule. With SKYWAY and SKYLINE Part A now fully enrolled, we are on track for the remaining five of our six planned Phase 2 readouts in 2026."

Preclinical data supporting the efficacy of anti-TL1A in rheumatic diseases will be presented on June 4 at the 2026 European Congress of Rheumatology (EULAR) in London.

Title: TL1A Inhibition is Efficacious in Mouse Models of Collagen-Induced Arthritis (CIA) and Imiquimod-Induced (IMQ) Psoriasis (POS0081)

Authors: M. Siegel, E. Lewis, D. Giles, J. LaFountaine, J.R. Friedman, A.G. Spencer

About SKYWAY and SPY072

The SKYWAY Phase 2 trial (NCT07148414) 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 proof-of-concept data are expected in Q3 (RA) and Q4 (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.

About Spyre Therapeutics

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

For more information, visit Spyre's website at www.spyre.com.

Forward-Looking Statements

Certain statements in this press release, other than purely historical information, may constitute "forward-looking statements" within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding: Spyre's ability to achieve the expected benefits or opportunities with respect to its product candidates, including their potential commercialization; Spyre's ability to deliver results on or ahead of schedule; Spyre's ongoing and future clinical development activities, including the expected timing, results and number of data readouts to be delivered for the ongoing SKYLINE trial and SKYWAY trial in 2026; the potential therapeutic benefits of SPY072, including its expected dosing profile and its potential as a first- and best-in-class anti-TL1A therapy in rheumatic diseases; estimated market sizes and potential growth opportunities; and Spyre's business plans, milestones, strategy and goals. The words "opportunity," "potential," "milestones," "pipeline," "strategy," "anticipate," "believe," "could," "estimate," "expect," "may," "might," "plan," "possible," "predict," "should," "will," "would," and similar expressions (including the negatives of these terms) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs and involve a number of risks and uncertainties, many of which are beyond Spyre's control, and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited, uncertainties and risks arising from regulatory feedback, including potential disagreement by regulatory authorities with the Company's interpretation of data and the Company's clinical trials for its product candidates; the potential for interim data not being delivered within expected time frames or final data not being consistent with or different than the interim data reported for our programs; the potential impact of Trump Administration policies and changes in law on our business; and those uncertainties and factors described in Spyre's most recent Annual Report on Form 10-K, as supplemented and updated by subsequent Quarterly Reports on Form 10-Q and any other filings that Spyre has made or may make with the SEC from time to time. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Spyre does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.

For Investors:     

Eric McIntyre, Spyre Therapeutics

SVP of Finance and Investor Relations

Eric.mcintyre@spyre.com

For Media:     

Josie Butler, 1AB

josie@1abmedia.com