Multiple centers in the U.S. are open for enrollment for double-blind, randomized, placebo-controlled study.

Primary endpoint will evaluate steroid-sparing effect of efzofitimod compared to placebo.

EFZO-FIT builds on positive results from Phase 1b/2a study which demonstrated dose dependent improvements across steroid reduction, lung function and symptom control endpoints.

SAN DIEGO, Sept. 27, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that it has dosed the first patient in the global pivotal EFZO-FIT study. The Phase 3 study will evaluate the efficacy and safety of the company's lead therapeutic candidate, efzofitimod, compared to placebo in patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD).

Efzofitimod is a first-in-class immunomodulator that downregulates innate and adaptive immune responses in uncontrolled inflammatory diseases states via selective modulation of neuropilin-2 (NRP2). The design of the EFZO-FIT study is supported by safety and efficacy data from a Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis. Efzofitimod has been granted FDA Orphan Drug and Fast Track designations for sarcoidosis.

"We are delighted to begin patient dosing in EFZO-FIT. With multiple centers in the U.S. open for enrollment, this very important study for patients with pulmonary sarcoidosis is underway," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "This is an important step forward to delivering a transformative, disease modifying therapy that we believe can reduce the burden of steroids and provide clinically meaningful outcomes for patients with this complex disease."

"We are excited to collaborate with aTyr as they advance this study of a promising new treatment that could potentially improve the lives of sarcoidosis patients worldwide," said Mary McGowan, Chief Executive Officer of the Foundation for Sarcoidosis Research.

The EFZO-FIT study is a global Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a 52-week study consisting 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 intends to enroll 264 subjects with pulmonary sarcoidosis at multiple centers in North America, Europe and Japan. The trial design will incorporate a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms.

More information on the EFZO-FIT study is available at (NCT05415137) and .