aTyr Pharma Gets FDA Fast Track Status For Systemic Sclerosis Candidate

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for aTyr Pharma’s LIFE lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis (SSc)-associated, interstitial lung disease (ILD).

The company is currently investigating efzofitimod in patients with pulmonary sarcoidosis in a global EFZO-FIT Phase 3 study.

Clinical proof-of-concept was recently established for efzofitimod in a Phase 1b/2a study in patients with pulmonary sarcoidosis.

Sanjay S. Shukla, President and CEO, commented: "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. 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 previously granted orphan drug designation for systemic sclerosis (SSc) from the regulatory agency.

Systemic sclerosis is a chronic, progressive, autoimmune disease distinguished by inflammation and fibrosis of connective tissues throughout the body, including the skin and other internal organs.

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

Price Action :  aTyr shares are trading around 4 percent higher on Tuesday during pre-market session.