{"url_path":"/sec/syre/8-k/2026-06-15/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-15","source_url":"https://www.sec.gov/Archives/edgar/data/1636282/0001636282-26-000083-index.html","accession_number":"0001636282-26-000083","cik":"0001636282","ticker":"SYRE","issuer_name":"Spyre Therapeutics, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1636282/0001636282-26-000083-index.html","primary_entity_key":"0001636282","primary_entity_name":"Spyre Therapeutics, Inc."},"word_count":360,"has_tables":true,"body_markdown":"Item 8.01 Other Events.\n\nOn June 15, 2026, the Company announced positive initial 12-week induction topline data from Part A of the Phase 2 SKYLINE trial of SPY002 for the treatment of moderately-to-severely active UC.\n\nSPY002 SKYLINE Part A Induction Topline Results\n\nInitial 12-week findings from SKYLINE Part A demonstrated that SPY002 met all key objectives. The study population consisted of 35% advanced therapy-exposed participants with a mean disease duration of 7.0 years, a mean baseline Robarts Histopathology Index (“RHI”) score of 16.9 ± 8.5 (SD), a mean modified Mayo Score (“mMS”) of 6.9 ± 1.0 (SD), and 56% of whom had a baseline endoscopy score of 3.\n\nEfficacy: SPY002 achieved the primary endpoint, demonstrating a statistically significant 10.7-point reduction in RHI score (p<0.0001), robust rates of clinical remission and endoscopic improvement, and a meaningful change in mMS, results that are among the highest reported in UC.\n\nEndpoint (Week 12)\n\nSPY002\n\nChange in RHI from baseline\n\nPrimary endpoint\n\n-10.7\n\n(p<0.0001)\n\nClinical remission rate\n\n33%\n\nEndoscopic improvement rate\n\n42%\n\nChange in modified Mayo Score\n\n-3.7\n\nSafety: SPY002 was well tolerated with a safety profile consistent with the TL1A class. There were twenty subjects with treatment-emergent adverse events (“TEAEs”) during the induction treatment period. Two serious adverse\n\nevents (“SAEs”) were reported, both deemed not drug-related. One case was for hospitalization for exacerbation of UC, the other case was for worsening of heart failure in a subject with a history of heart failure. The most common adverse events (“AEs”) (occurring in ≥ 2 patients) were arthralgia (n=2), hypertension (n=3), nausea (n=2), UC (n=2), and viral respiratory tract infection (n=2).\n\nSPY002 (n=48)\n\nSubjects with any AE (n, %)\n\n20 (41.7%)\n\nSevere (Grade ≥ 3) AE\n\n2 (4.2%)1,2\n\nDrug-related AE\n\n3 (6.3%)3\n\nAE leading to drug discontinuation\n\n2 (4.2%)2,4\n\nSAE\n\n2 (4.2%)1,2\n\nDrug-related SAE\n\n0\n\nAEs of special interest\n\n0\n\nDeath\n\n0\n\n1Hospitalization for exacerbation of UC in one subject, deemed not drug-related.\n\n2Hospitalization for worsening heart failure in one subject with history of heart failure and atrial fibrillation, who was subsequently diagnosed with worsening of aortic stenosis; deemed not drug-related.\n\n3One case each of nausea, hypertension, and arthralgia.\n\n4Exacerbation of UC, deemed not drug-related."}