aTyr Pharma advances Phase 3 efzofitimod study

• aTyr Pharma (NASDAQ:ATYR) received FDA alignment on the protocol for its planned Phase 3 efzofitimod study in pulmonary sarcoidosis.
• The global trial is expected to enroll approximately 372 patients and will evaluate lung function improvement over 54 weeks.
• aTyr plans to begin study activities in Q4 2026, including U.S. and European regulatory submissions.

aTyr Pharma (NASDAQ:ATYR) announced FDA alignment on the planned Phase 3 study protocol for efzofitimod in patients with pulmonary sarcoidosis on September 24, 2026.

The global randomized, placebo-controlled study is designed to evaluate efzofitimod in patients with symptomatic pulmonary sarcoidosis and restrictive lung disease.

The trial is expected to enroll up to approximately 372 patients, who will receive either 5 mg/kg efzofitimod or placebo intravenously every three weeks for 17 doses over 54 weeks.

The primary endpoint of the study will measure the change in forced vital capacity (FVC), a key indicator of lung function, at week 48. A lung-symptom questionnaire score will serve as a secondary endpoint.

aTyr said subgroup analysis from the previous Phase 3 EFZO-FIT study showed that patients with restrictive lung disease treated with 5.0 mg/kg efzofitimod demonstrated improvements in forced vital capacity and patient-reported outcomes compared with placebo.

The company expects to begin study-related activities during the fourth quarter of 2026, including regulatory submissions in the United States and Europe. Further development of efzofitimod will require additional capital.