other material
confidence high
sentiment negative
materiality 0.90
aTyr Pharma Phase 3 EFZO-FIT study misses primary endpoint in pulmonary sarcoidosis
aTYR PHARMA INC
- Primary endpoint: change from baseline in mean daily OCS dose at week 48; p=0.3313 (2.79 mg efzofitimod vs 3.52 mg placebo).
- Nominal KSQ-Lung score improvement for 5.0 mg/kg vs placebo (p=0.0479); steroid withdrawal with KSQ-Lung improvement p=0.0199.
- FVC maintained; safety consistent with prior trials; company plans to engage FDA on path forward.
- Study enrolled 268 patients; hierarchical testing stopped after primary miss; all subsequent p-values nominal.