Spyre Therapeutics Announces Poster Presentations at American College of Rheumatology (ACR) Convergence 2025

Rhea-AI Summary

Spyre Therapeutics (NASDAQ: SYRE) announced poster presentations at ACR Convergence 2025 on Oct 24, 2025 covering interim Phase 1 and preclinical data for SPY072.

Key points: six‑month follow‑up from the Phase 1 study shows SPY072 was reported as well tolerated, demonstrated a differentiated pharmacokinetic profile supporting quarterly (Q3M) or twice‑yearly (Q6M) dosing, and suppressed free TL1A through 20 weeks at the lowest dose. Preclinical rodent data were presented showing anti‑TL1A treatment met or exceeded etanercept efficacy in a collagen‑induced arthritis model. Posters relate to the ongoing SKYWAY Phase 2 basket study evaluating SPY072 in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Posters are available via the ACR program.

Insights

Clinical development & translational immunology expert

Phase 1 follow-up shows tolerability, durable target suppression to 20 weeks, and PK that could enable Q3M–Q6M dosing.

SPY072 is a half‑life‑extended anti‑TL1A monoclonal antibody with disclosed follow‑up data out to six months. The company reports that SPY072 was well tolerated, produced a differentiated pharmacokinetic profile consistent with potential quarterly (Q3M) or twice‑yearly (Q6M) maintenance dosing, and suppressed free TL1A through 20 weeks. Mechanistically, sustained target suppression plus extended PK supports less frequent dosing, which can materially affect patient convenience and treatment adherence if confirmed in larger studies.

Dependencies and risks remain clear and limited to what is disclosed: these are interim Phase 1 results and preclinical efficacy in a rodent collagen‑induced arthritis model. Safety, PK, pharmacodynamics, and clinical efficacy must be confirmed in controlled Phase 2 trials; early tolerability and biomarker suppression do not prove clinical benefit. The preclinical claim that anti‑TL1A treatment meets or exceeds etanercept in rodents provides biological validation but does not ensure translatability to humans.

Watch for three concrete items: full Phase 1 dataset publication for detailed safety and PK metrics, readouts from the ongoing SKYWAY Phase 2 basket study in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, and any formal dosing regimen decision informed by expanded PK/PD data. Expect meaningful updates around planned Phase 2 milestones and formal efficacy endpoints over the next 6–24 months.

WALTHAM, Mass., Oct. 24, 2025 (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 scientific presentations at the ACR Convergence Congress.

“We are excited to share follow-up data out to six months from our Phase 1 study of SPY072, our potential first- and best-in-class anti-TL1A agent in development for rheumatic diseases. The data continue to show SPY072 is well tolerated, has a differentiated PK profile supporting quarterly or twice-yearly dosing, and suppresses free TL1A through 20 weeks at the lowest dose,” said Josh Friedman, MD, PhD, SVP of Clinical Development at Spyre. “Additionally, we are pleased to share new preclinical data demonstrating that anti-TL1A antibody treatment meets or exceeds the efficacy of etanercept in a rodent model of collagen-induced arthritis, providing additional validation for our ongoing SKYWAY Phase 2 basket study evaluating SPY072 in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.”

The posters will be available for viewing during the ACR Convergence Congress, and details are as follows:

Title: Interim Phase 1 Results for SPY072, a Novel Half-Life Extended Monoclonal Antibody Targeting TL1A, Suggest A Potential for Q3M or Q6M Maintenance Dosing for Rheumatic Disease
Authors: Y. Vugmeyster, S. Sloan, JD Lu, K. Hew, P. Patel, C. Sheldon, D. Nguyen, R. McLean, M. Huyghe, B. Connolly, B. Wang, M. Kennedy, M. Rose, E. Svejnoha, J. Friedman

Title: TL1A Expression is Upregulated in Rheumatic Diseases and Anti-TL1A Antibody Reduces Disease Symptoms and Pathological Changes in Rat Collagen-Induced Arthritis
Authors: P. Patel, M. Siegel, E. Lewis, D. Giles, J. LaFountaine, J. Friedman, A. Spencer

Full session details can be accessed via the ACR program.

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, please visit http://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, concerning Spyre and other matters. These forward-looking statements include, but are not limited to, express or implied statements relating to Spyre's management team's expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, Spyre’s ability to achieve the expected benefits or opportunities with respect to its pipeline of product candidates such as the potential efficacy, tolerability, convenience, commercial viability, dosing regimen and safety profile of SPY072 in humans, including the potential for a quarterly or twice yearly dosing profile; the potential for SPY072 to become a first- and best-in-class therapy for rheumatic diseases; the potential consistency of the SPY072 Phase 2 trial final data readouts with interim Phase 1 results; and the potential therapeutic benefits of Spyre’s product candidates as monotherapies or in combinations and their extended half-life, including the expected efficacy and duration of half-life in comparison to competitor products. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "opportunity," "potential," "milestones," "pipeline," "can," "goal," "aim," "strategy," "target," "seek," "anticipate," "achieve," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "predict," "project," "should," "will," "would," and similar expressions (including the negatives of these terms or variations of them) 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 concerning future developments and their potential effects. There can be no assurance that future developments affecting Spyre will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Spyre's control) or 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 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 under the heading "Risk Factors," "Risk Factor Summary" and "Note about Forward-Looking Statements" in Spyre's most recent Annual Report on Form 10-K, as supplemented and updated by subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K that the Company has filed or will file with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in other filings by Spyre from time to time. Should one or more of these risks or uncertainties materialize, or should any of Spyre's assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. 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. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Spyre.

For Investors:     
Eric McIntyre
VP of Finance and Investor Relations
Spyre Therapeutics
Eric.mcintyre@spyre.com

For Media:     
Josie Butler, 1AB
josie@1abmedia.com

FAQ

What data did Spyre Therapeutics (SYRE) present at ACR Convergence 2025 on Oct 24, 2025?

Interim Phase 1 six‑month follow‑up for SPY072 showing tolerability, differentiated PK, and free TL1A suppression through 20 weeks, plus preclinical efficacy versus etanercept in a rodent model.

Does the Phase 1 SPY072 data support less frequent dosing for SYRE's drug candidate?

Yes; the data were reported to support a potential Q3M (quarterly) or Q6M (twice‑yearly) maintenance dosing schedule.

What preclinical comparison did Spyre present for SPY072 at ACR 2025?

Preclinical rodent collagen‑induced arthritis data reportedly showed anti‑TL1A treatment meets or exceeds the efficacy of etanercept in that model.

Which indications is Spyre evaluating SPY072 for in its SKYWAY Phase 2 basket study?

The SKYWAY Phase 2 basket study is evaluating SPY072 in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.

Where can investors view the Spyre posters presented at ACR Convergence 2025?

The posters are available for viewing during ACR Convergence and full session details can be accessed via the ACR program.