aTyr outlines a new Phase 3 sarcoidosis study after FDA discussions

aTyr Pharma ($ATYR) said it had aligned with the FDA on the design of a Phase 3 study of efzofitimod in pulmonary sarcoidosis patients with restrictive lung disease. The planned trial would enroll 372 patients and compare treatment with placebo over 54 weeks. Its primary endpoint would assess forced vital capacity at week 48, with patient-reported measures among the secondary outcomes.

The design draws on findings from the company’s earlier development program, but it is not a new demonstration of treatment benefit. aTyr expects to begin the necessary regulatory submission work in the fourth quarter and needs additional capital to advance the program. The announcement therefore establishes a proposed registrational path while leaving financing, trial execution and eventual efficacy results unresolved.

Sources:

• aTyr Pharma — FDA discussions and planned study