Enlivex Therapeutics has announced encouraging interim efficacy data from the Phase I stage of its Phase I/II clinical trial of Allocetra for treating moderate to severe knee osteoarthritis. The multi-center, randomized trial's initial phase focused on assessing the safety and tolerability of Allocetra injections, with the interim results indicating significant improvements in pain reduction and joint functionality compared to baseline.
The interim efficacy results demonstrated statistically significant improvements (p < 0.0007, n=12) across key endpoints three months post-treatment. Patients reported a 50% average reduction in knee joint pain, with average pain scores decreasing from 6.10 to 2.94 on a scale of 0-10. Additionally, there was a 42% improvement in average knee joint function and a 37% reduction in average knee joint stiffness, as measured by the WOMAC questionnaire (p < 0.0008 and p < 0.003, respectively).
Einat Galamidi, MD, Medical Vice President of Enlivex, highlighted the significance of these findings, stating, "These interim results may indicate that the novel mechanism of action of Allocetra may provide a treatment alternative for these osteoarthritis patients." She noted that osteoarthritis affects over 32.5 million Americans and is a leading cause of chronic pain and long-term disability, with currently no commercially available drugs proven to reverse disease progression.
Building on these positive results, Enlivex has commenced the Phase II stage of the trial. This phase is designed as a double-blind, randomized, placebo-controlled study to further evaluate the safety and efficacy of Allocetra injections into the knee. The trial will assess joint pain and function compared to placebo at three, six, and twelve months post-treatment. Initial dosing in Phase II has shown no safety concerns.
Allocetra is a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. This mechanism aims to rebalance the immune system and resolve inflammatory conditions like osteoarthritis. The Phase II trial is statistically powered to assess the efficacy of Allocetra injections, with key endpoints evaluating joint pain and function compared to placebo over a 12-month period.
Osteoarthritis is a prevalent condition, affecting over 32.5 million Americans and 300 million individuals worldwide. It is projected that 78 million Americans will have osteoarthritis by 2040. Currently, there are no FDA or EMA-approved medications that can arrest, slow, or reverse structural damage in the joint, underscoring the significant unmet need for effective treatments.
