Bimekizumab

SPY772 program aims to deliver best-in-indication efficacy and convenience in Hidradenitis Suppurativa through dual inhibition of TL1A and IL-17A/F in a long-acting coformulation Phase 2 SKYLIGHT trial designed to provide clinical proof-of-concept for TL1A and IL-17A/F inhibition in Hidradenitis Suppurativa; site activation has begun with topline Week 16 HiSCR75 data planned for late 2027 or early 2028 WALTHAM, Mass., Aug. 10, 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 launch of SPY772, a new combination program comprising SPY072, a long-acting anti-TL1A antibody, and SPY007, a novel long-acting anti-IL-17A/F antibody in preclinical development. To test the hypothesis of the SPY772 program, the company also announced the initiation of SKYLIGHT, a randomized Phase 2 proof-of-concept trial evaluating dual inhibition of TL1A and IL-17A/F in Hidradenitis Suppurativa (HS). “Combination therapy has demonstrated the ability to meaningfully improve efficacy without apparent safety downsides in multiple autoimmune conditions. We believe our differentiated strategy of developing long-acting antibody coformulations against validated targets appears increasingly likely to deliver indication-leading product pro ” said Sheldon Sloan, M.D., Chief Medical Officer. “Expanding our portfolio to include long-acting IL-17A/F broadens the potential for our pipeline to improve outcomes across some of the largest gastrointestinal, dermatologic, and rheumatic diseases with substantial remaining unmet medical need.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); "HS is a chronic, painful disease that can profoundly affect patients' quality of life, and many patients do not achieve adequate disease control with available therapies. We believe targeting complementary inflammatory pathways has the potential to raise the efficacy ceiling in HS," said Josh Friedman, M.D., Ph.D., SVP of Clinical Development and SKYLIGHT study lead. "SKYLIGHT will evaluate whether adding SPY072 (anti-TL1A) to bimekizumab (anti-IL-17A/F) can improve outcomes beyond bimekizumab alone. Positive SKYLIGHT results would support advancement of our long-acting SPY772 combination (SPY072 and SPY007) in HS. We are also excited to potentially explore other indications with this combination pending our SKYWAY trial results.” SKYLIGHT is a randomized, placebo-controlled Phase 2 proof-of-concept study expected to enroll approximately 150 adults with moderate-to-severe HS. Participants will receive background bimekizumab therapy and either SPY072 or placebo. The primary endpoint is the proportion of patients achieving a HiSCR75 response at Week 16. Topline results are expected in late 2027 or early 2028. 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, IL-23, and IL-17A/F as well as rational combination programs. For more information, visit Spyre's website at . 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 and combinations thereof, including its ability to develop next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients and its ability to develop long-acting antibody coformulations against validated targets to deliver indication-leading product pro the potential for SPY772 to provide best-in-indication efficacy and convenience in Hidradenitis Suppurativa through dual inhibition of TL1A and IL-17A/F in a long-acting coformulation; the potential of raising the efficacy ceiling in HS by targeting complementary inflammatory pathways; and Spyre’s ongoing and future pre-clinical and clinical development activities, including Spyre’s plans for and timing of data readouts and clinical enrollment for the SKYLIGHT trial, preclinical development of the SPY007 program and the potential expansion of the SPY772 program to indications outside of HS. The words "opportunity," "potential," "milestones," "pipeline," "strategy," "anticipate," "believe," "could," "estimate," "expect," "may," "might," "plan," "possible," "predict," "should," "will," "would," "can, " "likely," "aim," 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 to, 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 topline or 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