ENLV · Enlivex Therapeutics Ltd.

Summary

Enlivex Therapeutics Ltd. received Danish Medicines Agency approval for its Phase 2b trial of Allocetra in moderate-to-severe knee osteoarthritis, following recent FDA clearance, enabling patient enrollment in Denmark.

Key takeaways

• Danish Medicines Agency (DKMA) granted CTA approval for Phase 2b trial of Allocetra in age-related primary moderate-to-severe knee osteoarthritis.
• Approval follows recent FDA clearance for the trial in the United States.
• Trial is global, multicenter, randomized, double-blind, placebo-controlled, evaluating intra-articular Allocetra injections.
• Enrollment planned at clinical centers in United States, Denmark, and Poland.
• Endpoints include pain, physical function, quality-of-life, and mobility at 3- and 6-months post-treatment.