aTyr Pharma Reaches Final Patient Visit Milestone In Phase 3 EFZO-FIT™ Study For Pulmonary Sarcoidosis

aTyr Pharma, Inc., a clinical-stage biotechnology company developing novel medicines based on its proprietary tRNA synthetase platform, has announced the completion of patient participation in its Phase 3 EFZO-FIT™ study. The last patient in the trial has now completed their final visit, marking a significant milestone in the company’s clinical development of its lead therapeutic candidate, efzofitimod.

The EFZO-FIT™ study is focused on evaluating efzofitimod as a potential treatment for pulmonary sarcoidosis, one of the most common forms of interstitial lung disease. Pulmonary sarcoidosis is a chronic condition characterized by inflammation and granuloma formation in the lungs, often leading to reduced lung function and quality of life. Efzofitimod, a first-in-class immunomodulator derived from aTyr’s tRNA synthetase research platform, is designed to target the underlying immune pathways involved in this disease.

Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr, stated, “Completing this first-ever global Phase 3 and largest interventional study conducted for patients with sarcoidosis to date is a major accomplishment for aTyr and the broader sarcoidosis community. Current treatment options for sarcoidosis are limited and rely heavily on the use of oral corticosteroids, which often have significant side effects.”

He also added, “This study provides an opportunity to evaluate a treatment such as efzofitimod that may have the potential to reduce steroid burden and improve quality of life in patients with this chronic disease. We thank the patients, investigators, patient advocacy organizations and our partner Kyorin Pharmaceutical Co., Ltd. for helping to make this study possible, and we look forward to sharing topline results later this quarter.”

aTyr Pharma completes Phase 3 EFZO-FIT™ trial for efzofitimod in pulmonary sarcoidosis. Topline results expected in Q3 2025 to guide next steps.

With all patients having completed the trial, aTyr now moves closer to a key data readout. The company expects to report topline results from the EFZO-FIT™ study in the third quarter of 2025. These results will be critical in assessing the safety and efficacy of efzofitimod and may inform future regulatory and commercialization strategies. This announcement represents an important step in aTyr’s mission to develop targeted therapies for serious immune-mediated diseases and brings the company closer to potentially offering a new treatment option for patients affected by pulmonary sarcoidosis.