(RTTNews) - aTyr Pharma, Inc. (ATYR), on Friday announced that the independent Data and Safety Monitoring Board or DSMB has completed a fourth pre-planned interim safety analysis for the ongoing Phase 3 EFZO-FIT study of efzofitimod in patients with pulmonary sarcoidosis.
The DSMB found no safety concerns and recommended that the study proceed without any modifications.
The EFZO-FIT study is a 52-week, randomized, double-blind, placebo-controlled trial involving 268 patients with pulmonary sarcoidosis. Participants are receiving either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or a placebo.
The study is being conducted at multiple sites across the U.S., Europe, Japan, and Brazil, with the primary endpoint being steroid reduction. Topline results are expected in the third quarter 2025.
The positive review reinforces aTyr's confidence in the safety profile of efzofitimod. The company aims to position efzofitimod as a chronic, maintenance therapy for pulmonary sarcoidosis that can potentially reduce or eliminate the need for oral corticosteroids.
Efzofitimod is a first-in-class biologic immunomodulator designed to treat interstitial lung diseases or ILD, including pulmonary sarcoidosis.
The treatment selectively modulates activated myeloid cells, aiming to resolve inflammation without suppressing the immune system and potentially preventing fibrosis progression.
ATYR closed Thursday's (Mar. 06, 2025) trading at $3.08, up 2.22 percent. In after-hours, the stock was up by 10.07 percent at $3.39 on the Nasdaq.
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