aTyr Pharma announces results from Phase 3 EFZO-FIT study

aTyr Pharma (ATYR) announced topline results from the Phase 3 EFZO-FIT study of efzofitimod in 268 patients with pulmonary sarcoidosis, a major form of interstitial lung disease. The study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid, OCS, dose at week 48. The change from baseline in mean daily OCS dose reduced to an average of 2.79 mg for 5.0 mg/kg efzofitimod vs 3.52 mg for placebo. The study’s statistical analysis plan was designed on a hierarchical assessment basis, as such since the primary endpoint was not met, all subsequent statistical testing is reported as nominal findings. The study demonstrated a clinical improvement in the King’s Sarcoidosis Questionnaire-Lung score at week 48 for 5.0 mg/kg efzofitimod compared to placebo, with a responder analysis of patients who achieved complete steroid withdrawal at week 48 with an improved KSQ-Lung score also showing improvement in patients treated with 5.0 mg/kg efzofitimod compared to placebo. Lung function as measured by forced vital capacity, FVC, at week 48 was maintained.