Spyre Announces Acceleration of Expected Topline Readout of SKYWAY Rheumatoid Arthritis Sub-study to Q3 2026

Recruitment for the rheumatoid arthritis (RA) sub-study of the SKYWAY basket trial is complete; Week 12 topline data now expected in Q3 2026

Recruitment for the psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) sub-studies of SKYWAY remain on track; Week 16 topline readouts expected in Q4 2026

SKYLINE platform trial in ulcerative colitis (UC) continues to enroll ahead of schedule; Part A readouts to begin in Q2 2026

WALTHAM, Mass., March 16, 2026 (GLOBE NEWSWIRE) -- Spyre Therapeutics, Inc. (NASDAQ:SYRE), a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (IBD) and rheumatic diseases, today announced the completion of recruitment for the RA sub-study of the SKYWAY basket trial and acceleration of expected topline readout to Q3 2026.

"Enrollment in the RA sub-study of SKYWAY has exceeded our expectations and reflects both substantial unmet need as well as investigator enthusiasm for the potential of a long-acting anti-TL1A antibody," said Joshua Friedman, M.D., Ph.D., SVP of Clinical Development and SKYWAY study lead. "We look forward to delivering the first proof-of-concept data for this mechanism in rheumatic disease in the third quarter, with the potential to advance to pivotal trials next year. Together with readouts from the SKYLINE study, we now expect key data from Spyre's programs in IBD and rheumatic diseases in every subsequent quarter this year."

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 pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease ("IBD") and rheumatic diseases. 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 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 and expectations regarding timing of pivotal trials, if any; the potential therapeutic benefits of Spyre's product candidates as monotherapies or in combinations, including potency, convenience, durability, and dosing profile, and their extended half-life; 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

[email protected]

For Media:     

Josie Butler, 1AB

[email protected]