SPY120 / Spyre Therap - LARVOL DELTA

SKYLINE-UC: The First Platform Study in Ulcerative Colitis Assessing Efficacy and Safety of Three Long-Acting Antibodies Administered as Single Agents and in Combinations (ECCO-IBD 2026) - "The aim of this study is to assess the efficacy & safety of SPY001, SPY002, and SPY003 as single agents & in pairwise combinations (SPY120 [SPY001 & SPY002], SPY130 [SPY001 & SPY003], SPY230 [SPY002 & SPY003]) in UC through a patient-centric study design that enables sharing of data from placebo and monotherapy treatment arms, thereby minimizing the number of participants assigned to placebo and enrolled overall. Conclusion SKYLINE-UC is an innovative platform study that will evaluate 6 interventions, including 3 single agents and 3 pairwise combinations. The study is designed to provide proof of concept for each investigational monotherapy and combination compared to placebo, dose-ranging data on each monotherapy, and a preliminary assessment of the additive and/or synergistic benefit of combinations."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

Additionally, we are pleased to share new preclinical data demonstrating that each of our combination programs (α4β7 + TL1A, α4β7 + IL-23, and TL1A + IL-23) exhibit superior efficacy relative to constituent monotherapies in rodent TNBS-induced colitis models... (GlobeNewswire) - "The poster will be available for viewing during the UEGW Congress..."

Preclinical • Inflammatory Bowel Disease • Ulcerative Colitis

Spyre Therapeutics Announces Poster Presentation at the 20th Congress of the European Crohn’s and Colitis Organisation (PRNewswire) - "Spyre Therapeutics, Inc...today announced a poster presentation at the 20th Congress of the European Crohn's and Colitis Organisation (ECCO), held February 19-22, 2025, in Berlin, Germany, showing that combined inhibition of α4β7 integrin and TL1A cytokine is superior to either monotherapy in mouse models of colitis and coadministration demonstrates no drug-drug effects on exposure in non-human primates (NHPs)...'We are thrilled to share these recent preclinical findings supporting the combination potential for our SPY120 program...demonstrating that combined inhibition of the α4β7 integrin and TL1A cytokine provide additive or greater than additive efficacy relative to inhibition of either target alone,'...'We look forward to testing all three potential best-in-indication combinations in our Phase 2 trial in ulcerative colitis patients which is expected to begin mid-year.'"

New P2 trial • Preclinical • Inflammatory Bowel Disease • Ulcerative Colitis