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
Related News:- aTyr Pharma Reports the First Patient Dosing in the P-III (EFZO-FIT) Study of Efzofitimod for the Treatment of Pulmonary Sarcoidosis