aTyr Pharma, Inc. announced that its Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis did not meet its primary endpoint. The primary endpoint was the change from baseline in mean daily oral corticosteroid (OCS) dose at week 48.
Despite missing the primary endpoint, clinical benefit for efzofitimod was observed across multiple study parameters. Specifically, 52.6% of patients treated with 5.0 mg/kg efzofitimod achieved complete steroid withdrawal at week 48, compared to 40.2% on placebo, with a p-value of 0.0919.
Clinical improvement in the King’s Sarcoidosis Questionnaire (KSQ)-Lung score at week 48 was observed in the 5.0 mg/kg efzofitimod treatment group versus placebo, with a p-value of 0.0479. The study also showed greater preservation of forced vital capacity (FVC) in the 5.0 mg/kg efzofitimod group, and the drug was generally well-tolerated.
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