Enlivex Announces Positive 6-Month Topline Data –Demonstrating Durable and Persistent Pain Reduction and Improved Function in Primary Age-Related Patients with Moderate to Severe Knee Osteoarthritis

Core Insights - Enlivex Therapeutics announced positive six-month efficacy data from the Phase IIa stage of its Allocetra™ trial for knee osteoarthritis, reaffirming previous three-month results and identifying an age-related responder population [1][4][6] Summary of Six-Month Data - The six-month follow-up has been completed for all patients, showing substantial and durable reduction in pain and improvement in function for patients aged 60 and above, compared to placebo [1][6] - At six months, Allocetra™ demonstrated a statistically significant improvement of -27.8 points in the treated group versus -15.5 points in the placebo group, corresponding to an 80% improvement over the control group [6] Clinical Development and Future Trials - Enlivex plans to initiate a Phase IIb trial in the first half of 2026 to further evaluate Allocetra™ in age-related primary knee osteoarthritis [4][6] - The trial's design includes an interim statistical evaluation to identify potential responder sub-groups, enhancing future development strategies [7] Osteoarthritis Context - Osteoarthritis affects over 32.5 million Americans and more than 300 million individuals globally, with projections indicating that 78 million Americans will have osteoarthritis by 2040 [8] - The condition is particularly prevalent among older adults, with significant implications for healthcare systems due to its disabling nature and the lack of approved treatments that address structural damage [8] Company Overview - Enlivex is focused on macrophage reprogramming immunotherapy, developing Allocetra™ as a universal cell therapy aimed at rebalancing the immune system [9]