What changed
SPY003 met its primary endpoint in SKYLINE Part A with a statistically significant 10.0-point reduction from baseline in Robarts Histopathology Index at Week 12 (p=0.0001). Secondary endpoints included clinical remission by modified Mayo Score of 20% and endoscopic improvement of 30%. SPY003 was well tolerated with a safety profile consistent with the IL-23 class. Part B evaluating pairwise combinations is enrolling with topline induction data expected in 2027.