Efzofitimod Gets Fast Track Status for Pulmonary Sarcoidosis

The Food and Drug Administration (FDA) has granted Fast Track designation to efzofitimod (ATYR1923) for treatment of pulmonary sarcoidosis.

Efzofitimod is a potential first-in-class selective modulator of neuropilin-2 that is designed to downregulate innate and adaptive immune responses in inflammatory disease states. The investigational drug is a fusion protein comprised of the immunomodulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody.

The Company is currently evaluating the efficacy and safety of efzofitimod in the multicenter, randomized, double-blind, placebo-controlled phase 3 EFZO-FIT study (ClinicalTrials.gov Identifier: NCT05415137). This study is enrolling adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid, with or without immunosuppressant therapy.

“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, MD, 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.”

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