aTyr Pharma Announces Publication of Results from the Phase 3 EFZO-FIT™ Study of Efzofitimod in Pulmonary Sarcoidosis in The Lancet Respiratory Medicine
Key Highlights
- ➤EFZO-FIT missed its primary endpoint for week-48 corticosteroid reduction versus placebo
- ➤268-patient Phase 3 study found efzofitimod improved multiple patient-reported outcomes
- ➤Efzofitimod maintained lung function and was generally well-tolerated
- ➤aTyr initiated study-related activities for a global Phase 3 pulmonary sarcoidosis study
- ➤Efzofitimod is being investigated in Phase 2 systemic-sclerosis-related interstitial lung disease
Expert Statements
Daniel Culver, D.O., Chair of the Division of Pulmonary Medicine at the Cleveland Clinic and lead author
“The findings from this largest interventional, randomized, controlled trial ever conducted in pulmonary sarcoidosis represent an important advancement in our understanding of how patients can be appropriately managed with steroids and is likely to lead to a paradigm shift in the way that we treat sarcoidosis patients and evaluate new therapies for this patient population in the future.”
Daniel Culver, D.O., Chair of the Division of Pulmonary Medicine at the Cleveland Clinic and lead author
“There is an urgent need for safe, effective and tolerable treatments for sarcoidosis that have a positive impact on patient quality of life.”
Daniel Culver, D.O., Chair of the Division of Pulmonary Medicine at the Cleveland Clinic and lead author
“The study not only demonstrated that a large reduction of steroids was possible in all patients in the study, but remarkably, efzofitimod improved multiple PRO measures, including those specific to sarcoidosis, and warrants further investigation in this patient population.”
Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr Pharma
“Publication of the EFZO-FIT™ results strengthens the evidence supporting efzofitimod and brings greater visibility to its differentiated clinical profile.”
Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr Pharma
“The improvements across multiple PROs, together with preserved lung function and a favorable safety profile, reinforce our confidence in efzofitimod’s potential and provide a strong foundation for its continued development in pulmonary sarcoidosis.”
SAN DIEGO, Oct. 29, 2026 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the publication of results from the Phase 3 EFZO-FIT™ study of its lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis, a major form of interstitial lung disease, in The Lancet Respiratory Medicine. The publication, entitled, “Efzofitimod versus placebo in patients with pulmonary sarcoidosis (EFZO-FIT): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial,” is available on the journal’s website and at: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(26)00283-3/abstract.
EFZO-FIT™ was a global Phase 3 interventional study in 268 patients with moderate to severe pulmonary sarcoidosis that was designed to address patient and physician needs by investigating the impact of efzofitimod on steroid reduction and key patient-reported outcomes (PROs) through a protocol guided steroid taper.
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