The global, multicenter, randomized, double-blind, placebo-controlled Phase 2b clinical trial is designed to evaluate the efficacy and safety of intra-articular injections of Allocetra™ in patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis, which is one of the most prevalent and disabling diseases worldwide, affecting more than 32 million Americans today and projected to impact 78 million Americans by 2040. The trial is enrolling patients from clinical centers in the United States, Denmark and Poland. Key efficacy endpoints include changes from baseline of pain and physical function compared with placebo, measured at three- and six-month periods following treatment. Additional endpoints include changes in quality-of-life measures and functional mobility assessments.

Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, "Dosing the first patient in the United States marks a significant step in the execution of our global Phase 2b strategy for Allocetra™. The United States represents the largest clinical site network for this trial, and initiating enrollment there reflects the momentum we have built following FDA IND clearance and DKMA approval. Our Phase 1/2a data demonstrated a robust, durable, and clinically meaningful treatment effect in the patient population that is the center focus of this Phase 2b trial, and we believe that we are positioned to generate the data needed to move forward to the last stages of clinical development and offer a therapy that will address a significant unmet need for aging patients with this debilitating disease."