aTyr Pharma reaches FDA alignment on Phase 3 protocol for efzofitimod in pulmonary sarcoidosis

aTYR PHARMA INC

• Study to start Q4 2026; global, randomized, double-blind, placebo-controlled, 54-week trial.
• Two parallel cohorts: 5.0 mg/kg efzofitimod vs placebo IV every 3 weeks for 17 doses; up to 372 patients.
• Primary endpoint: change from baseline FVC at week 48; key secondary: KSQ-Lung score change at week 48.
• Design supported by EFZO-FIT subgroup data showing clinically meaningful FVC and patient-reported improvements.
• Company expects to need additional capital via equity/debt, grants, collaborations, or licensing for study.