Enlivex Announces Positive Interim Data Readout from a Phase I/II Trial Evaluating Allocetra in End-Stage Knee Osteoarthritis

Core Insights - Enlivex Therapeutics Ltd. announced positive interim data from a Phase I/II clinical trial of AllocetraTM for patients with end-stage knee osteoarthritis, indicating a potential alternative to knee replacement surgery [1][3]. Clinical Trial Results - In a three-month follow-up, only 1 out of 9 patients (11%) opted for knee replacement surgery, while 8 patients (89%) chose not to proceed with the surgery [2][7]. - Patients reported an average pain reduction of 64% from baseline, with 33% of patients experiencing complete pain relief, reducing their average pain level from 9 to 0 on a scale of 0 to 10 [7][8]. - The trial demonstrated a favorable safety profile, with no severe adverse events related to AllocetraTM reported [7][16]. Background on Osteoarthritis - Osteoarthritis affects over 32.5 million Americans and more than 300 million individuals globally, with projections indicating that 78 million Americans will have the condition by 2040 [5]. - The disease leads to over one million hospitalizations annually in the U.S., primarily for total joint replacement, highlighting the critical need for effective treatments [5]. About Allocetra™ - Allocetra™ is designed as a universal, off-the-shelf cell therapy aimed at reprogramming macrophages into their homeostatic state, which is essential for immune system rebalancing [12][18]. - The therapy is being explored for various conditions, including solid cancers and sepsis, addressing significant unmet medical needs [18]. Future Directions - The ongoing study aims to enroll a total of 18 patients, with assessments for safety and pain/function responses extending up to 12 months post-injection [17].