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aTyr Pharma Receives FDA Fast Track Designation for Efzofitimod for Treatment of Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Second Fast Track designation for efzofitimod clinical program. Efzofitimod previously received FDA orphan drug designation for systemic sclerosis (SSc). SAN
About this update from Atyr Pharma, Inc.
[{"type":"text","content":"Second Fast Track designation for efzofitimod clinical program. Efzofitimod previously received FDA orphan drug designation for systemic sclerosis (SSc). SAN DIEGO, Sept. 13, 2022 (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 announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for its lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis (SSc, also known as scleroderma)-associated, interstitial lung disease (ILD). 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, a major form of ILD, and the company is currently investigating efzofitimod in patients with pulmonary sarcoidosis in a global Phase 3 study called EFZO-FIT™. “This Fast Track designation reflects the potential of efzofitimod to address a significant unmet need for patients with SSc- ILD, which is the leading cause of death in scleroderma patients,” said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr. “As highlighted in the ILD sessions at the recent European Respiratory Society International Congress, it is clear that there is a need for more effective and safer therapies for fibrotic lung diseases, including sarcoidosis and ILD that results from scleroderma. We believe this designation further validates efzofitimod and greatly expands the market potential for this first-in-class therapeutic.” Efzofitimod has been shown to reduce lung and skin fibrosis in animal models of SSc and idiopathic pulmonary fibrosis, where it matched or outperformed known anti-fibrotic agents, including nintedanib and pirfenidone. The pathology of SSc-ILD is driven by the same immune cells that are central to pulmonary sarcoidosis pathology, and NRP2 is upregulated on these cells. Efzofitimod has also been shown to reduce key pro-inflammatory markers that are central to this pathology in a clinical study in patients with pulmonary sarcoidosis. Based on these findin...