SAN DIEGO, Calif. — 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 that the Company will present a subgroup analysis of the Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease, at the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) 2026 Congress, which is scheduled to take place July 15 – 17, 2026, in Porto, Portugal.
“This subgroup analysis of patients from EFZO-FIT™ with restrictive lung disease presents clear evidence that those treated with efzofitimod experienced a clinically meaningful benefit in lung function and positive trends of improvement in multiple patient-reported outcomes (PROs) while removing steroids,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr Pharma. “Following our recent interactions with the U.S. Food and Drug Administration (FDA), last month we submitted a protocol for a planned Phase 3 study in pulmonary sarcoidosis patients with restrictive lung disease (defined as forced vital capacity, or FVC, percent predicted ≤ 80% with a normal FEV1/FVC ratio), utilizing FVC as the primary endpoint of the study and the King’s Sarcoidosis Questionnaire (KSQ)-Lung score as the key secondary endpoint. We believe the approach of investigating efzofitimod in this defined patient population where FVC is the relevant measure of lung function is a well-informed plan to demonstrate the potential for efzofitimod to improve the lives of these patients.”
Details of the poster presentation appear below. The poster will be available on the aTyr website once presented.
Title: Evaluating Efzofitimod in a Subset of Sarcoidosis with the Restrictive Phenotype
Authors: Vis Niranjan, Pavithra Ramesh, Sanjay Shukla, Nelson Kinnersley, Daniel A. Culver. RxMD, aTyr Pharma, Octa Consulting Services, Cleveland Clinic.
Poster Number: PO123
Session: Controversies in Sarcoidosis Treatment and Disease Progression
Date and Time: Thursday, July 16, 2026, at 1:15pm WEST
Location: Porto, Portugal
EFZO-FIT™ included 264 pulmonary sarcoidosis patients with all lung phenotypes who were enrolled and treated (intent-to-treat, or ITT). The post hoc analysis included a subset of 44 patients with prespecified restrictive lung disease (FVCpp ≤ 80%, FEV1/FVC ≥ 0.7). The change from baseline at week 48 for FVC and PROs was analyzed using a random coefficient regression model (RCRM) to supplement the mixed model for repeated measures (MMRM) analysis performed for the ITT data. The baseline characteristics were generally balanced in the restrictive patients compared to the ITT population, however mean FVC was expectedly lower. Overall, the magnitude of steroid reduction in the 5.0 mg/kg efzofitimod arm was similar to placebo. In the 5.0 mg/kg efzofitimod arm, the placebo adjusted week 48 change from baseline for FVC by RCRM was 123.8 ml. The placebo adjusted week 48 change from baseline by RCRM showed improvement for the 5.0 mg/kg efzofitimod arm versus placebo for KSQ-Lung, KSQ-General Health, Fatigue Assessment Scale, and the Leicester Cough Questionnaire. Furthermore, efzofitimod was generally well tolerated in the restrictive subgroup, similar to the ITT. The findings suggest that further investigation of efzofitimod in patients with restrictive lung disease is warranted.
About the EFZO-FIT™ study
EFZO-FIT™ was a global Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis with all lung phenotypes. The 52-week study consisted of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously once a month for a total of 12 doses. The study enrolled 268 subjects (264 enrolled and treated) with pulmonary sarcoidosis at multiple centers in the United States, Europe, Japan and Brazil. The trial design incorporated a forced steroid taper. The primary endpoint of the study was steroid reduction at week 48. Secondary endpoints included measures of sarcoidosis symptoms and lung function at week 48.
About Pulmonary Sarcoidosis
Pulmonary sarcoidosis is an inflammatory disease characterized by the formulation of granulomas, clumps of inflammatory cells, in one or more organs of the body. Approximately 160,000 Americans are diagnosed with pulmonary sarcoidosis and the prognosis ranges from benign and self-limiting to chronic, debilitating disease, permanent loss of lung function and death. Current treatment options include corticosteroids and other immunosuppressive therapies, which have limited efficacy and are associated with serious side-effects that many patients cannot tolerate long-term.
About Efzofitimod
Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod is currently being investigated in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD, and aTyr recently submitted a protocol to the FDA for a global Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.
About aTyr
aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit www.atyrpharma.com.
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