Core Insights - Enlivex Therapeutics Ltd. announced positive interim six-month efficacy data from the Phase I stage of its Allocetra™ trial for knee osteoarthritis, showing significant pain reduction and improved functionality [1][2][4] Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to restore immune balance [6] Clinical Trial Details - The Phase I/II trial consists of two stages: the completed Phase I safety run-in and the ongoing Phase II double-blind, randomized, placebo-controlled trial [1][3] - The Phase I stage demonstrated a 47.0% average reduction in reported pain and significant improvements in functionality and stiffness, with 83% of patients still responding to treatment after six months [2][4] Efficacy Results - The six-month interim results showed a 51.2% reduction in WOMAC pain, a 46% improvement in WOMAC function, and a 40% improvement in WOMAC stiffness, indicating durable efficacy [2][4] - The safety profile of Allocetra™ remained consistent, with no serious adverse events reported [2][4] Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and projected to reach 78 million by 2040, highlighting the critical need for effective treatments [4][5]
Enlivex Announces Positive Interim Data – Statistically Significant 47.0% Durable and Persistent Pain Reduction At Six Months, in Patients with Moderate to Severe Knee Osteoarthritis