aTyr Pharma plans Phase 3 pulmonary sarcoidosis trial of efzofitimod with FVC endpoint

• aTyr Pharma mapped a new Phase 3 trial plan for efzofitimod in chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease, shifting strategy following an FDA Type C meeting that reviewed results from Phase 3 EFZO-FIT.
• EFZO-FIT results were already presented to FDA; next pivotal study will test whether efzofitimod can preserve lung function and improve patient-reported breathing-related well-being versus placebo in a more defined, higher-severity population.
• Company plans to submit an IND in June 2026; trial design calls for a 54-week, global, randomized, double-blind study of intravenous 5.0 mg/kg dosing every three weeks.
• Planned study size up to 372 patients; primary readout set for week 48, with a patient-reported outcome positioned as a key secondary endpoint.

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