SAN DIEGO, September 15, 2025 — Leads & Copy — aTyr Pharma, Inc. (Nasdaq: ATYR) announced topline results from its Phase 3 EFZO-FIT™ study of efzofitimod in 268 patients with pulmonary sarcoidosis. While the study did not meet its primary endpoint, clinical benefit was observed across multiple study parameters.
52.6% of patients treated with 5.0 mg/kg efzofitimod achieved complete steroid withdrawal at week 48 vs 40.2% on placebo (p=0.0919). A clinical improvement in King’s Sarcoidosis Questionnaire (KSQ)-Lung score at week 48 was observed in the 5.0 mg/kg efzofitimod treatment group vs placebo (p=0.0479). A greater proportion of patients achieved complete steroid withdrawal at week 48 with a KSQ-Lung score improvement in the 5.0 mg/kg efzofitimod treatment group (29.5%) vs placebo (14.4%) (p=0.0199). Efzofitimod was well-tolerated with a consistent safety profile.
The company plans to engage with the U.S. Food and Drug Administration (FDA) to determine the path forward for efzofitimod in pulmonary sarcoidosis. Management hosted a conference call and webcast today at 8:30am ET / 5:30am PT.
Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr Pharma.
Source: aTyr Pharma, Inc.
