Efzofitimod - (EFZO-FIT)

August 7, 2026: aTyr Pharma (NASDAQ: ATYR) said it is prioritizing efzofitimod in interstitial lung disease and cutting its workforce by about 60% to conserve capital ahead of FDA feedback expected by the end of August 2026 on a Phase 3 protocol submitted in June 2026 for pulmonary sarcoidosis.

For pulmonary sarcoidosis, the planned Phase 3 study would be a global, randomized, double-blind, placebo-controlled 54-week trial in up to about 372 patients with chronic, symptomatic disease and restrictive lung disease. Patients would receive 5.0 mg/kg efzofitimod or placebo every 3 weeks for 17 doses. The primary endpoint is change from baseline in FVC at week 48; key secondary endpoint is change in King’s Sarcoidosis Questionnaire-Lung score at week 48.

For SSc-ILD, enrollment has completed in the Phase 2 EFZO-CONNECT study; topline results are expected in Q1 2027. The 28-week proof-of-concept trial enrolled 23 U.S. patients and randomized them 2:2:1 to 270 mg, 450 mg, or placebo monthly for six doses.

The company also reported a post hoc EFZO-FIT Phase 3 subgroup analysis presented at WASOG 2026 showing clinically meaningful FVC benefit and improvement in multiple patient-reported outcomes with 5.0 mg/kg efzofitimod versus placebo in restrictive lung disease. Cash at June 30, 2026 was $58.9 million, with runway into late 2028; restructuring is expected to lower annualized operating expenses by about $13 million starting Q4 2026.