aTyr Pharma, Inc. announced that an independent data and safety monitoring board (DSMB) recommended that the ongoing Phase 3 EFZO-FIT? study of its lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis could continue without any modifications after a second pre-planned, interim analysis. EFZO-FIT?

is a global Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously once a month for a total of 12 doses. The study intends to enroll up to 264 subjects with pulmonary sarcoidosis at multiple centers in the United States, Europe, Japan and Brazil.

The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms.