Clinical TrialMay 18, 2026, 08:07 AM
Enlivex Doses First US Patient in Phase 2b Allocetra Trial for OA
AI Summary
Enlivex Ltd. announced the dosing of the first patient at a United States clinical site in its global Phase 2b clinical trial of Allocetra for moderate-to-severe age-related symptomatic primary knee osteoarthritis. This milestone follows FDA IND clearance in March 2026 and Danish Medicines Agency approval in April 2026. The trial aims to evaluate the efficacy and safety of Allocetra, with key endpoints including changes in pain and physical function at three and six months, addressing a significant unmet medical need.
Key Highlights
- Enlivex dosed the first patient in the US for its Phase 2b clinical trial of Allocetra for moderate-to-severe knee osteoarthritis.
- The trial is a global, multicenter, randomized, double-blind, placebo-controlled study.
- It evaluates intra-articular injections of Allocetra in age-related symptomatic primary knee osteoarthritis.
- The trial is enrolling patients from clinical centers in the United States, Denmark, and Poland.
- Key efficacy endpoints include changes in pain and physical function at three and six months.
- The enrollment follows FDA IND clearance in March 2026 and Danish Medicines Agency (DKMA) approval in April 2026.
- Knee osteoarthritis affects over 32 million Americans today, projected to impact 78 million by 2040.
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