Enlivex Doses First U.S. Patient in Phase 2b Trial of Allocetra for Knee Osteoarthritis

On May 18, 2026, Enlivex Ltd. announced the dosing of the first patient at a United States clinical site in its Phase 2b clinical trial of Allocetra™ for the treatment of moderate-to-severe age-related symptomatic primary knee osteoarthritis (OA). This milestone follows the FDA's Investigational New Drug (IND) clearance received in March 2026 and approval from the Danish Medicines Agency (DKMA) in April 2026. The trial is a global, multicenter, randomized, double-blind, placebo-controlled study enrolling patients across the United States, Denmark, and Poland. The study is designed to evaluate the efficacy and safety of intra-articular injections of Allocetra™. Key efficacy endpoints include changes from baseline in pain and physical function compared to placebo, measured at three and six months post-treatment. Enlivex aims to address a significant unmet need in the knee OA market, which currently lacks approved disease-modifying therapies. The company previously reported robust and durable treatment effects from its Phase 1/2a data in this patient population. Additionally, the company highlighted its dual strategy of developing longevity therapeutics alongside a prediction markets treasury strategy.