ATYR aTyr Pharma

aTyr Pharma Aligns with FDA on Phase 3 Protocol for Efzofitimod in Pulmonary Sarcoidosis

aTyr reached alignment with the FDA on the protocol for a global Phase 3 randomized placebo-controlled study of efzofitimod (5.0 mg/kg IV every 3 weeks) in patients with moderate to severe pulmonary sarcoidosis with restrictive lung disease. The 54-week trial will enroll up to 372 patients on stable background therapy with primary endpoint of FVC change at week 48. Study-related activities are planned to begin in Q4 2026, supported by positive subgroup data from the prior EFZO-FIT Phase 3 study.

aTyr: Phase 3 EFZO-FIT misses primary endpoint in pulmonary sarcoidosis

The Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid dose at week 48. Despite missing the primary endpoint, the company observed clinical benefit for the 5.0 mg/kg dose across multiple pre-specified secondary efficacy parameters and plans to meet with the FDA in Q1 2026 to determine the path forward.