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aTyr Pharma Announced Topline Results From The Phase 3 EFZO-FIT Study Of Efzofitimod In Pulmonary Sarcoidosis, The Study Did Not Meet Its Primary Endpoint

Author: Benzinga Newsdesk | September 15, 2025 06:32am

Study did not meet primary endpoint in change from baseline in mean daily oral corticosteroid (OCS) dose at week 48, although clinical benefit for efzofitimod 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).
Clinical improvement in King's Sarcoidosis Questionnaire (KSQ)-Lung score at week 48 observed in the 5.0 mg/kg efzofitimod treatment group vs placebo (p=0.0479).
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.
Company plans to engage with the U.S. Food and Drug Administration (FDA) to determine the path forward for efzofitimod in pulmonary sarcoidosis.

Posted In: ATYR