aTyr Pharma, Inc. (ATYR) Monday said that its Phase 3 EFZO-FIT study of efzofitimod in patients with pulmonary sarcoidosis, a major form of interstitial lung disease, failed to meet its primary goal.
In the study, the change from baseline in mean daily oral corticosteroid (OCS) dose at week 48, the primary endpoint, was an average of 2.79 mg for 5 mg/kg efzofitimod compared to 3.52 mg for placebo.
At week 48, 52.6% of patients receiving 5.0 mg/kg efzofitimod achieved complete steroid withdrawal, compared with 40.2% of those on placebo.
The company plans to work with the U.S. Food and Drug Administration (FDA) to decide next steps for efzofitimod in pulmonary sarcoidosis.
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