Efzofitimod - (EFZO-FIT)

September 1, 2026: aTyr Pharma, Inc. (NASDAQ: ATYR) said it expects a mid-September 2026 FDA response on the protocol it submitted in June 2026 for a planned Phase 3 trial of efzofitimod in chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease.

The planned Phase 3 study is described as a global, randomized, double-blind, placebo-controlled trial in moderate to severe pulmonary sarcoidosis. It is expected to run 54 weeks, enroll about 372 patients, and randomize patients equally to efzofitimod 5.0 mg/kg or placebo given intravenously every 3 weeks for 17 doses. Eligible patients are expected to be on a stable dose of no more than 5.0 mg daily oral corticosteroid and/or a background immunosuppressant, with background treatment remaining stable during the trial.

The primary endpoint is change from baseline in forced vital capacity at week 48; the key secondary endpoint is change from baseline in King’s Sarcoidosis Questionnaire-Lung score at week 48.

Separately, the company said efzofitimod is also being studied in the Phase 2 EFZO-CONNECT trial in systemic sclerosis-related interstitial lung disease.