aTyr Pharma redesigns Phase 3 trial for efzofitimod after FDA feedback, targets narrower patient group

Filed May 11, 2026 · Period ending May 11, 2026 · ~1 min read

Key Changes

• high

  aTyr will launch new Phase 3 trial focusing on pulmonary sarcoidosis patients with restrictive lung disease (FVC ≤80%), using lung capacity as primary endpoint instead of previous design. IND submission planned for June 2026.

  Item 7.01 verify on EDGAR →
• high

  Dosing frequency increased to every 3 weeks (from every 4 weeks) based on FDA discussions about benefit-risk profile. Trial will include enhanced safety monitoring and data safety committee oversight.

  Item 7.01 verify on EDGAR →
• high

  New global trial will enroll approximately 372 patients over 54 weeks. Design based on subgroup showing 124 ml FVC improvement in 44 restrictive disease patients from prior EFZO-FIT study.

  Item 7.01 verify on EDGAR →