Enlivex Announces Completion of Enrollment In The Phase II stage Of Its Phase I/II Trial Evaluating Allocetra In Patients With Moderate To Severe Knee Osteoarthritis

Core Insights - Enlivex Therapeutics has completed patient enrollment for the Phase II stage of its clinical trial for Allocetra™ in treating moderate to severe knee osteoarthritis, involving a total of 133 patients [1][2][3] - The company aims to release topline data by August 2025, following promising initial efficacy results from the Phase I stage [2][3] Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, which is designed to restore macrophages to their homeostatic state [5] - The company emphasizes the potential of Allocetra™ to transform osteoarthritis treatment, addressing a significant unmet medical need [2][4] Clinical Trial Details - The Phase I/II trial consists of a safety run-in and a double-blind, randomized, placebo-controlled Phase II stage, with an independent data safety and monitoring board overseeing safety evaluations [3] - Positive interim results from the Phase I stage showed significant improvements in key efficacy endpoints without safety issues [3] Osteoarthritis Context - Osteoarthritis affects over 32.5 million Americans and more than 300 million people globally, with projections indicating that 78 million Americans will have the condition by 2040 [4] - The disease leads to significant healthcare burdens, including over one million hospitalizations annually in the U.S. for joint replacements, highlighting the critical need for effective treatments [4]