Clinical TrialJul 15, 2026, 08:02 AM
aTyr Pharma's Efzofitimod Shows Benefit in Lung Disease; Plans Phase 3
AI Summary
aTyr Pharma announced positive subgroup analysis results from its Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis patients with restrictive lung disease. The 5.0 mg/kg dose demonstrated clinically meaningful benefit in lung function (FVC) and improvements in patient-reported outcomes compared to placebo. Following these results and interactions with the FDA, the company submitted a protocol for a planned Phase 3 study of efzofitimod in this specific patient population, utilizing FVC as the primary endpoint.
Key Highlights
- Efzofitimod 5.0 mg/kg showed clinically meaningful FVC benefit in restrictive lung disease.
- Placebo-adjusted FVC change was 123.8 ml at week 48 for 5.0 mg/kg efzofitimod.
- Improvements seen in KSQ-Lung, KSQ-General Health, Fatigue Assessment, and Leicester Cough.
- Company submitted Phase 3 study protocol to FDA in June 2026 for efzofitimod.
- Planned Phase 3 study targets pulmonary sarcoidosis with restrictive lung disease.
- FVC will be the primary endpoint for the planned Phase 3 study.
- Subgroup analysis included 44 patients with prespecified restrictive lung disease.
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