Previewing Phase 2 SKYWAY Rheumatoid Arthritis Data Expected in 3Q26: SPY072 Could Pioneer First-in-Class Efficacy for TL1A Inhibitors Beyond IBD

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Previewing Phase 2 SKYWAY Rheumatoid Arthritis Data Expected in 3Q26: SPY072 Could Pioneer First-in-Class Efficacy for TL1A Inhibitors Beyond IBD

A clean safety readout for SYRE's TL1A inhibitor could unlock the TNF-refractory RA market where most FDA-approved

therapies carry boxed warnings. There are currently >10 FDA-approved biologic therapies for RA, divided across four major

mechanistic classes: TNF inhibitors (Humira [adalimumab], Enbrel [etanercept], Remicade [infliximab], Cimzia [certolizumab], and

Simponi [golimumab]), interleukin inhibitors (Kineret [anakinra] targeting IL-1, and Actemra [tocilizumab] and Kevzara [sarilumab]

targeting IL-6); B-cell depleting agents (Rituxan [rituximab]); and JAK inhibitors (Xeljanz [tofacitinib], Olumiant [baricitinib], and

Rinvoq [upadacitinib]). Despite the numerous treatment options, significant safety concerns persist across all approved classes.

The majority of these classes carry FDA boxed warnings (aside from Kineret [anakinra]) for serious and potentially fatal infections,

including tuberculosis (excluding Rituxan [rituximab]), bacterial sepsis, and invasive fungal infections such as histoplasmosis,

coccidioidomycosis, aspergillosis, candidiasis, and other infections due to opportunistic pathogens. Malignancy risk, particularlyBIOTECHNOLOGY lymphoma, is observed with TNF and JAK inhibitors, while chronic leukemia cases have been reported only in the labels of

TNF inhibitors. Rituximab carries unique safety warnings, including fatal infusion reactions, Tumor Lysis Syndrome (TLS), severe

mucocutaneous reactions, and Progressive Multifocal Leukoencephalopathy (PML). Beyond serious infections and malignancies,

Rinvoq carries additional warnings for Major Adverse Cardiovascular Events (MACE) and thrombosis.