Amgen says HORIZON Phase 3 achieves ‘statistically significant’ improvement

Amgen presented topline data from the Phase 3 ROCKET-HORIZON study of focatinlimab for patients with Atopic Dermatitis. The co-primary endpoint for U.S.: ASI-75 and rIGA 0/1 at week 24 and Ex-US: EASI-75 and vIGA-AD 0/1 at week 24, while key secondary endpoints included: vIGA-AD 0/1 at week 16, EASI-75 at week 16, EASI-90 at week 24. Amgen said that there was a statistically significant improvement observed in co-primary endpoints: 32.8% of rocatinlimab treated subjects achieved an EASI-75 response at week 24 vs. 13.7% placebo (19.1% difference, less than 0.001); 19.3% of rocatinlimab treated subjects achieved a vIGA-AD 0/1 response at week 24 vs. 6.6% placebo (12.8% difference, less than 0.001); 16.4% of rocatinlimab treated subjects achieved a rIGA 0/1 response at week 24 vs. 4.9% placebo (11.5% difference, less than 0.001). In addition, the company said all key secondary endpoints met statistical significance and that overall safety results were comparable to the Phase 2b trial. Separately, the company provided an update on Uplinza, saying the first global placebo controlled, randomized controlled trial in IgG4-R met the primary endpoint, demonstrating a clinically meaningful and statistically significant 87% reduction in IgG4-RD flare risk at 52-weeks compared to placebo (HR = 0.13, p less than 0.0001), and all three key secondary endpoints met statistical significance after multiplicity adjustment.