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aTyr Pharma Announces Phase 2 Study of Efzofitimod in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) Following FDA Clearance of IND Application
Proof-of-Concept study in SSc-ILD expected to begin in 2023. Efzofitimod has been granted U.S. FDA orphan drug designation for SSc and Fast Track designation
About this update from Atyr Pharma, Inc.
[{"type":"text","content":"Proof-of-Concept study in SSc-ILD expected to begin in 2023. Efzofitimod has been granted U.S. FDA orphan drug designation for SSc and Fast Track designation for SSc-ILD. SAN DIEGO, March 01, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today provided additional details regarding its plans to initiate a Phase 2 study of its lead therapeutic candidate, efzofitimod, in patients with systemic sclerosis (SSc, also known as scleroderma)-associated interstitial lung disease (ILD) following the clearance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) announced earlier this year. Efzofitimod is a potential first-in-class immunomodulator that downregulates innate and adaptive immune responses in uncontrolled inflammatory disease states via selective modulation of neuropilin-2 (NRP2). The company is currently investigating efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD, in a global Phase 3 study called EFZO-FIT™. “We are thrilled to expand our efzofitimod clinical program to include a Phase 2 study in SSc-ILD with clearance of this IND, which is supported by preclinical data showing efzofitimod reduces lung and skin fibrosis in an animal model of SSc-ILD and clinical data demonstrating proof-of-concept for efzofitimod in patients with pulmonary sarcoidosis,” said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr. “ILD is the leading cause of death in patients with scleroderma. Current treatment options may help to slow lung function decline but do not impact underlying disease or improve quality of life. There remains a medical need for more effective and safer therapies for patients with this debilitating disease.” “Efzofitimod’s clinical proof-of-concept in sarcoidosis as well as the translational effects seen in an animal model of SSc-ILD provide strong rationale to evaluate this novel immunomodulator in patients with ILD that results from an underlying rheumatologic condition such as scleroderma,” said Kristin Highland, M.D., Director, Rheumatic Lung Disease Program at the Cleveland Clinic. “The prospect of a new therapeutic target for scleroderma-associated lung disease is welcome news f...