Enlivex Secures Danish Approval for Global Phase 2b Allocetra Knee Osteoarthritis Trial
Enlivex received Danish Medicines Agency approval to initiate its global, multicenter Phase 2b trial of Allocetra in moderate-to-severe age-related knee osteoarthritis, following recent FDA clearance. The randomized, double-blind, placebo-controlled study will enroll patients in the United States, Denmark and Poland to assess pain, function and quality-of-life endpoints.
1. Regulatory Approvals
Enlivex has obtained Clinical Trial Application approval from the Danish Medicines Agency (DKMA) to enroll patients in Denmark for its Phase 2b trial of Allocetra in moderate-to-severe age-related knee osteoarthritis, following FDA clearance in the United States.
2. Trial Design
The global, multicenter, randomized, double-blind, placebo-controlled study will recruit patients across clinical centers in the United States, Denmark and Poland, with key efficacy endpoints including changes in pain and physical function at three and six months post-treatment, as well as quality-of-life and mobility assessments.
3. Implications
This regulatory milestone advances Enlivex’s strategy to generate robust clinical data on Allocetra’s immunomodulatory mechanism, potentially addressing the unmet need for disease-modifying therapies in a market projected to affect 78 million Americans by 2040 and informing future commercial and development decisions.