Spyre Therapeutics Announces Positive Interim Phase 1 Results for SPY003, Its Novel, Half-Life Extended anti-IL-23 Antibody

Core Insights - Spyre Therapeutics announced positive interim Phase 1 results for SPY003, an investigational extended half-life antibody targeting IL-23, which supports its potential for quarterly or biannual maintenance dosing [1][2][8] Group 1: Clinical Trial Results - SPY003 demonstrated a favorable safety profile in a Phase 1 trial with 59 healthy adult participants, showing it was well tolerated across all dose levels [3][5] - The trial included various dosing cohorts, with the most common treatment-emergent adverse event being headache, and no serious adverse events reported [3][4] - SPY003 exhibited a half-life of approximately 85 days, significantly longer than risankizumab, indicating potential for less frequent dosing [5][8] Group 2: Future Development Plans - The positive results from the Phase 1 trial will allow SPY003 to advance to the ongoing Part A of the SKYLINE Phase 2 platform trial [1][2] - The SKYLINE and SKYWAY trials are expected to yield six proof-of-concept readouts by 2026, further validating the efficacy and safety of SPY003 [1][2] Group 3: Company Overview - Spyre Therapeutics is focused on developing long-acting antibodies and antibody combinations to improve treatment standards for inflammatory bowel disease (IBD) and rheumatic diseases [9] - The company’s pipeline includes investigational therapies targeting α4β7, TL1A, and IL-23, aiming to create a comprehensive IBD portfolio [2][9]