Spyre abandons standalone RA ambitions for SPY072 after modest Phase 2 results

Spyre Therapeutics is deprioritizing SPY072 as a rheumatoid arthritis monotherapy after Phase 2 results failed to meet the company’s efficacy threshold.

In the 143-patient SKYWAY RA sub-study, 12-week DAS28-CRP scores fell 1.9 points with the low dose, 1.5 points with the high dose, and 1.3 points with placebo. Only the low-dose result was statistically significant versus placebo.

ACR20 response rates were 58% for the low dose, 63% for the high dose, and 43% for placebo. However, the placebo-adjusted benefit was considered too modest to justify advancing the drug alone in RA.

SPY072 was generally well tolerated, with adverse-event rates comparable to placebo and no new safety concerns reported.

Spyre said the data still provide proof of mechanism for TL1A inhibition in RA. The company plans to focus on SPY072 in other autoimmune diseases and potentially as part of combination therapies; results in psoriatic arthritis and axial spondyloarthritis are expected later in 2026.

Sources:

Spyre's rheumatoid arthritis plan toppled by subpar TL1A data

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