SPY230 / Spyre Therap - LARVOL DELTA

Disproportionality analysis of semaglutide-associated bile-duct cancer: A vigibase study. (PubMed, Indian J Gastroenterol) - "While this study identifies a potential safety signal between semaglutide use and bile duct cancer, causality cannot be established. These findings underscore the importance of ongoing pharmacovigilance and the need for long-term observational studies and randomized controlled trials."

Journal • Biliary Cancer • Cardiovascular • Cholangiocarcinoma • Diabetes • Metabolic Disorders • Oncology • Pancreatic Cancer • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma

Anti-TL1A and anti-IL-23 combination therapy is superior to its constituent monotherapies in mouse anti-CD40 colitis (ECCO-IBD 2026) - "Conclusion The combination of anti-TL1A and anti-IL-23 was more efficacious in mouse anti-CD40 colitis than anti-TL1A and anti-IL-23 monotherapies. These preclinical results support advancement of SPY230 in the ongoing SKYLINE-UC Phase 2 platform study in UC."

Combination therapy • Preclinical • Immunology • Inflammatory Bowel Disease • IL23A

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