Drug intelligence / Profile preview

SPY002

Development stage
Phase 2
Lead developer
Spyre Therapeutics
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous
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Overview

SPY002 is a novel, extended half-life fully human IgG1 monoclonal antibody that binds soluble TL1A (tumor necrosis factor-like cytokine 1A) with high affinity and specificity, potently inhibiting TL1A-mediated signaling. It is being developed as a highly potent and selective anti-TL1A therapy for inflammatory and fibrotic diseases, including inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, and rheumatoid arthritis. The molecule has been engineered for increased half-life to enable infrequent subcutaneous dosing (potentially quarterly or twice-yearly). Preclinical studies have shown that SPY002 candidates demonstrate equivalent or superior potency compared to first-generation anti-TL1As and significantly longer half-lives. Spyre Therapeutics is advancing two versions of the molecule (SPY002-091 and SPY002-072) through Phase 1 clinical trials in healthy volunteers; Phase 2 trials in IBD are planned pending successful results[1][3][4][6].

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