Spyre Therapeutics reported early positive Phase 2 results for SPY001 in ulcerative colitis, with SKYLINE Part A showing safety and the primary endpoint met.

The news drove a roughly 25% jump in Spyre's stock after the Phase 2 results were announced.

Recruitment for Part A has closed and Part B is now enrolling, evaluating three monotherapy cohorts and three combination cohorts of SPY001 with SPY002 and SPY003.

SPY001 is being developed as a potential improvement over existing anti-alpha4beta7 therapies.

Spyre’s release notes AI-assisted article generation and editorial review of the announcement.

In 12-week Part A data, SPY001 achieved a statistically significant 9.2-point reduction in the Robarts Histopathology Index, indicating histological improvement.

The SKYLINE Part A trial enrolled 43 patients; SPY001 showed a safety profile consistent with anti-alpha4beta7 antibodies, with six treatment-emergent adverse events during induction, one unrelated serious AE, and back pain most common (in two patients).

STAT+ exclusive coverage notes that full data require a subscription, with publicly available excerpts confirming initial positive results but not the complete data set.

Secondary endpoints showed a 40% clinical remission rate and 51% endoscopic improvement, alongside a 3.7-point decline in the Modified Mayo Score from baseline.

Analysts expect proof-of-concept induction data for SPY002 in mid-2026 and SPY003 in Q3 2026, with Part B induction data for all cohorts on track for 2027.

The announcement covers one of Spyre’s three drug candidates and signals potential progression toward broader development and competition in ulcerative colitis.

Across SKYLINE Part A, SPY001 yielded an average 9.2-point drop in disease activity and about 40% of participants achieved remission after 12 weeks.