aTyr Pharma Announces Phase 3 EFZO-FIT™ Study Results for Efzofitimod in Pulmonary Sarcoidosis


2025-09-15SEC Filing 8-K (0001193125-25-202865)

aTyr Pharma, Inc. announced topline results from its Phase 3 EFZO-FIT™ study of efzofitimod in 268 patients with pulmonary sarcoidosis. The study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid (OCS) dose at week 48. However, the study demonstrated clinical improvement in the King’s Sarcoidosis Questionnaire (KSQ)-Lung score at week 48 for the 5.0 mg/kg efzofitimod dose compared to placebo. Additionally, a greater proportion of patients achieved complete steroid withdrawal with an improved KSQ-Lung score in the 5.0 mg/kg efzofitimod group. Lung function, as measured by forced vital capacity (FVC), was maintained. The Company plans to engage with the U.S. Food and Drug Administration (FDA) to review the results and determine the path forward for efzofitimod in pulmonary sarcoidosis. The drug was generally well-tolerated at both the 3.0 mg/kg and 5.0 mg/kg doses.


Tickers mentioned in this filing:ATYR

TradeFomo: SEC Filing 8-K (0001193125-25-202865) for ATYR