Kyorin Pharmaceutical's KRP-R120 fails to meet primary endpoint in phase 3 trial

The EFZO-FIT™ study, an international Phase 3 trial for KRP-R120 (efzofitimod) targeting pulmonary sarcoidosis, did not achieve its primary endpoint. The trial, conducted across 10 countries, evaluated KRP-R120 (3mg/kg and 5mg/kg) against placebo, showing no statistically significant difference in the change in daily oral corticosteroid (OCS) dosage from baseline after OCS tapering. At 48 weeks, the 5mg/kg group averaged 2.79mg of OCS daily, compared to 3.52mg for the placebo group.

Although the primary endpoint was not met, secondary analyses showed some positive trends. At 48 weeks, the 5mg/kg group demonstrated a 52.6% corticosteroid-free rate (compared to 40.2% for placebo) and an improvement in KSQ-Lung score of 10.36 (compared to 6.19 for placebo). Additionally, 29.5% of patients in the 5mg/kg group achieved both KSQ-Lung score improvement and corticosteroid-free status (compared to 14.4% for placebo). KRP-R120 exhibited a favorable safety profile with no new risks identified.

Kyorin Pharmaceutical and aTyr Pharma will now engage in discussions regarding the future development plan for KRP-R120. The costs associated with this trial have already been factored into the consolidated earnings forecast for the fiscal year ending March 2026.