SPY072 - (SKYWAY-RD, basket study)

Aug. 25, 2026: Spyre Therapeutics (NASDAQ: SYRE) reported topline Phase 2 SKYWAY-RA results for SPY072 in rheumatoid arthritis. Both doses showed statistically significant benefit vs placebo on at least one efficacy endpoint at Week 12, but the effect size did not meet the company’s bar to prioritize SPY072 monotherapy in RA.

In SKYWAY-RA, low-dose SPY072 met the primary endpoint with a greater DAS28-CRP reduction than placebo (-1.9 vs -1.3; p<0.05). High-dose SPY072 showed nominal significance on ACR20 (63% vs 43% placebo), and low-dose showed nominal significance on ACR50 (38% vs 19% placebo). ACR70 rates were 13% for high dose, 4% for low dose, and 2% for placebo. Results were generally comparable in advanced-therapy-naive and experienced patients. Both doses achieved target drug concentrations and complete, durable suppression of free TL1A through Week 12.

SPY072 was described as well tolerated: adverse events were 27% on active treatment vs 36% on placebo; one serious TEAE occurred in each arm, none drug-related; one death occurred on placebo.

Upcoming catalysts: SKYWAY PsA and axSpA topline data are expected in 4Q 2026; SKYLINE Part A in ulcerative colitis (SPY003) in Sept. 2026; SKYLINE Part B in UC in 2027; and SKYLIGHT in hidradenitis suppurativa testing SPY072 plus IL-17A/F in late 2027 or early 2028.