aTyr Pharma Receives FDA Fast Track Designation for Efzofitimod (ATYR1923) for Treatment of Pulmonary Sarcoidosis

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[{"type":"text","content":"Company is investigating efzofitimod in global pivotal Phase 3 EFZO-FIT™ study in pulmonary sarcoidosis patients\nSAN DIEGO, Aug. 11, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (aTyr or “the Company”), a clinical stage biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for its lead therapeutic candidate, efzofitimod (ATYR1923), for the treatment of pulmonary sarcoidosis, a major form of interstitial lung disease. Efzofitimod is a first-in-class immunomodulator that downregulates innate and adaptive immune responses in uncontrolled inflammatory disease 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, and the company is currently investigating efzofitimod in a global pivotal phase 3 study called EFZO-FIT™. Efzofitimod previously received FDA orphan drug designation for the treatment of sarcoidosis. “The Fast Track designation for efzofitimod underscores the significant need for a new therapy that provides clinically meaningful outcomes for patients living with pulmonary sarcoidosis,” said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr. “Fast Track designation reinforces the potential of this novel immunomodulator to be a transformative, disease modifying therapy and address a major unmet need for the sarcoidosis community. We are currently investigating efzofitimod in a global pivotal Phase 3 study called EFZO-FIT™ and we look forward to the opportunity to work closely with the FDA to potentially expedite the delivery of a new treatment to patients in need.” “The designation of Fast Track for efzofitimod is important news for the many sarcoidosis patients who remain on prednisone for controlling their disease,” said Robert P. Baughman, M.D., Emeritus Profess of Medicine at the University of Cincinnati. “The last drugs approved by the FDA for sarcoidosis were prednisone and other glucocorticoids in the 1950s and most sarcoidosis patients with chronic disease remain on prednisone, with or without other agents which have not been approved by the FDA.” The FDA’s Fast Track design...

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