other material
confidence high
sentiment positive
materiality 0.75
Ultragenyx and Mereo report setrusumab cuts fracture rate 67% and boosts BMD 22% in OI Phase 2
Ultragenyx Pharmaceutical Inc.
- Median annualized fracture rate reduced 67% from 0.72 to 0.00 (p=0.0014) over mean 16 months in 24 patients.
- Lumbar spine BMD increased 22% from baseline at month 12 (p<0.0001); Z-score normalized from -1.73 to -0.49.
- No treatment-related serious adverse events or hypersensitivity reactions; most common AEs: infusion-related events, headache.
- Phase 3 portion of Orbit study enrolled 158 patients; Cosmic study enrolled 69 patients; 14-month data to be presented at future meeting.