- The U.S. Food and Drug Administration (FDA) granted fast track designation to aTyr Pharma's ( NASDAQ: LIFE ) lead drug candidate efzofitimod to treat systemic sclerosis (SSc, also known as scleroderma)-associated, interstitial lung disease (ILD).
- SSc is a progressive, autoimmune disease characterized by inflammation and scarring of connective tissues in the body. SSc which occurs in the lungs is called SSc-ILD.
- Clinical proof-of-concept was seen for efzofitimod in a phase 1b/2a trial in patients with pulmonary sarcoidosis, a form of ILD, the company said in a Sept. 13 press release.
- aTyr noted that it is currently investigating efzofitimod in patients with pulmonary sarcoidosis in a global phase 3 study called EFZO-FIT.
- The company added that it was the second fast track designation for efzofitimod clinical program and therapy had previously received the FDA's orphan drug designation for SSc
- LIFE +8.11% to $4.00 premarket Sept. 13
For further details see:
aTyr Pharma stock rises on FDA fast track status for efzofitimod for lung disease