aTyr Pharma’s EFZO-FIT™ Trial Gains 3rd Positive Data And Safety Monitoring Board Review

aTyr Pharma, Inc., a clinical-stage biotech company focused on developing novel medicines derived from its proprietary tRNA synthetase platform, has announced the results of a pre-planned interim safety review for its Phase 3 EFZO-FIT™ trial. The review, conducted by an independent Data and Safety Monitoring Board (DSMB), concluded that the trial could proceed without any changes.

The EFZO-FIT™ study is a global Phase 3 trial designed to evaluate the safety and effectiveness of efzofitimod, aTyr’s leading therapeutic candidate, in treating pulmonary sarcoidosis. This randomised, double-blind, placebo-controlled study involves 268 participants across the United States, Europe, Japan, and Brazil. Over 52 weeks, participants receive one of three monthly intravenous treatments: 3.0 mg/kg or 5.0 mg/kg doses of efzofitimod, or a placebo, for 12 doses.

Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr, said in a statement, “We are pleased to report yet another positive safety review for efzofitimod, which includes all 268 patients that have been enrolled in our global pivotal Phase 3 EFZO-FIT™ study. Safety is paramount when looking to provide a disease-modifying treatment for a chronic condition such as pulmonary sarcoidosis, where reducing or replacing a toxic standard of care such as oral corticosteroids could be highly meaningful and improve quality of life for patients.”

The trial includes a mandatory reduction in steroid use, with its primary objective focused on steroid tapering. Secondary goals assess lung function and the severity of sarcoidosis symptoms.