aTyr Pharma, Efzofitimod, Systemic Sclerosis-Associated Interstitial Lung Disease, Clinical Trial, P-II Study
- The company plans to initiate the P-II PoC study efzofitimod (270/450mg) vs PBO in a ratio (2:2:1), following the IND clearance from the US FDA. Additionally, ~25 patients will enroll with progressive disease who are currently receiving background mycophenolate therapy at multiple centers in the US
- The primary objective will be to evaluate the efficacy of multiple doses of efzofitimod (IV) on pulmonary, cutaneous & systemic manifestations & secondary objectives incl. safety & tolerability
- Efzofitimod is being studied in the P-III study (EFZO-FIT) for pulmonary sarcoidosis. The P-Ib/IIa study of efzofitimod showed safety & consistent dose-response, trends of benefit on key efficacy EPs incl. steroid reduction, lung function, clinical symptoms & inflammatory biomarkers
Ref: aTyr Pharma | Image: aTyr Pharma
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