aTyr Pharma expects FDA response on Phase 3 sarcoidosis trial by mid-Sept

aTyr Pharma, Inc. (Nasdaq: ATYR) said it expects to receive a response from the U.S. Food and Drug Administration by mid-September 2026 regarding a protocol the company submitted in June 2026 for a planned Phase 3 study of efzofitimod in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease.

The planned Phase 3 trial is designed as a global, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of efzofitimod in patients with moderate to severe pulmonary sarcoidosis. The 54-week study would enroll up to approximately 372 patients across two parallel cohorts, randomized equally to receive either 5.0 mg/kg efzofitimod or a placebo, administered intravenously once every three weeks for a total of 17 doses.

Eligible patients would be those receiving a stable dose of 5.0 mg or less of daily oral corticosteroid and/or a background immunosuppressant, with all background treatment remaining stable throughout the study duration.

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

Efzofitimod is a biologic immunomodulator in clinical development for interstitial lung disease. The drug is also being investigated in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis-related interstitial lung disease.

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