Spyre reports mixed phase 2 results for SPY072 in arthritis

WALTHAM, Mass. - Spyre Therapeutics Inc. (NASDAQ:SYRE) unveiled the Phase 2 SKYWAY trial results for SPY072 in rheumatoid arthritis on <date>. Both dosages exhibited statistically significant advantages over placebo on at least one metric. The lower dose notably improved the primary endpoint, DAS28-CRP change from baseline, at Week 12, while the higher dose showed marginal significance in the ACR20 secondary endpoint.

At Week 12, the high dose group experienced a -1.5 alteration in DAS28-CRP, contrasting with -1.3 for placebo. The low dose group saw a -1.9 change. Regarding ACR20, the high dose attained 63% compared to 43% for placebo, and the low dose reached 58%. For ACR50, the high dose reached 31% and the low dose 38%, compared to 19% for placebo.

The medicine had a favorable safety profile with adverse event rates of 27% for active treatment versus 36% for placebo. Most adverse events were mild or moderate. A serious adverse event occurred in each arm, but none were attributed to the drug. One death occurred in a placebo group participant. The company stated the clinical significance did not meet its internal criteria to prioritize SPY072 monotherapy development in rheumatoid arthritis.

The study enrolled 143 patients with moderate to severe RA who had insufficient response to standard or innovative therapies. Spyre anticipates topline data for SPY072 in psoriatic arthritis and axial spondyloarthritis to be available in the fourth quarter of 2026. Additionally, the company expects data for SPY072 in combination with IL-17A/F in hidradenitis suppurativa in late 2027 or early 2028.