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aTyr Pharma Announces Phase 3 Study of Efzofitimod (ATYR1923) in Pulmonary Sarcoidosis
Global pivotal EFZO-FIT™ study expected to begin in the third quarter of 2022 Primary endpoint will evaluate steroid sparing effect of efzofitimod compared to
About this update from Atyr Pharma, Inc.
[{"type":"text","content":"Global pivotal EFZO-FIT™ study expected to begin in the third quarter of 2022 Primary endpoint will evaluate steroid sparing effect of efzofitimod compared to placebo SAN DIEGO, May 16, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines from its proprietary tRNA synthetase platform, today announced a Phase 3 study evaluating the efficacy and safety of its lead therapeutic candidate, efzofitimod (ATYR1923), in patients with pulmonary sarcoidosis. The study, which will be known as EFZO-FIT™, is expected to initiate in the third quarter of 2022. 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 will be 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. 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). Clinical proof-of-concept was recently established for efzofitimod in a Phase 1b/2a study in patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD). “We are very pleased with the input we received from the FDA regarding the design of this important study of efzofitimod in pulmonary sarcoidosis patients,” said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr. “We aligned with the FDA on the prioritization of efficacy endpoints, with a primary focus on steroid reduction, which is clinically meaningful to patients and providers. This late-stage study is a major milestone for aTyr and the sarcoidosis community, and we look forward to the expected initiation of the study in the third quarter of this year.” “This study is a major step forward in developing a new treatment for pati...