aTyr Pharma (NASDAQ:ATYR) said it plans to conduct a new Phase III trial of efzofitimod in pulmonary sarcoidosis after receiving feedback from the U.S. Food and Drug Administration at a recent Type C meeting.
President and CEO Dr. Sanjay Shukla said the meeting, held in mid-April with official minutes received last week, was intended to review results from the completed Phase III EFZO-FIT study and determine the next steps for the program. EFZO-FIT missed its primary endpoint of steroid reduction, but Shukla said the study showed “durable benefit” on several prespecified quality-of-life measures, including the King’s Sarcoidosis Questionnaire, or KSQ, lung score, the KSQ general health score and the fatigue assessment score.
