Enlivex Therapeutics (NASDAQ: ENLV) announced today that the first patient has been dosed in a Phase I clinical trial evaluating Allocetra™ for the treatment of temporomandibular joint (TMJ) osteoarthritis. The study, conducted at Sheba Medical Center in Israel, represents the first time Allocetra has been administered directly into the TMJ and marks a new therapeutic application for the company’s macrophage reprogramming platform.
- The trial is the first to evaluate Allocetra for TMJ osteoarthritis, a condition affecting up to 12% of the global population
- TMJ osteoarthritis currently has no effective long-term treatments and can result in chronic jaw pain, stiffness, and even joint replacement in severe cases
The study will enroll six patients who have failed conventional therapy. Its primary focus is to assess safety and tolerability, while secondary endpoints will evaluate reductions in pain and improvements in joint functionality over a 12-month period. According to Enlivex, the initial patient dosing was completed successfully and without complications.
Primary endpoints will assess adverse events; secondary endpoints will track functional and symptomatic improvements for up to one year post-treatment
Allocetra is Enlivex’s lead investigational therapy and is being developed as a universal, off-the-shelf cell therapy designed to reset macrophages—the key immune cells involved in inflammation—back to a healthy, homeostatic state. In diseases such as cancer, sepsis, and osteoarthritis, macrophages often become dysregulated, amplifying disease severity. By reprogramming them, Allocetra may offer a novel, immune-modulating approach to conditions that lack effective therapies.
Allocetra is a macrophage-reprogramming therapy currently in clinical studies for cancer, sepsis, and now TMJ osteoarthritis
TMJ osteoarthritis is the second most common musculoskeletal disorder worldwide, affecting up to 12% of people and costing an estimated $4 billion annually in healthcare expenses. Despite its prevalence and impact, treatment options remain limited to symptom management or invasive surgery in advanced cases.
This new indication expands Enlivex’s clinical reach and represents a potential strategic foothold in a large, underserved market. The trial is being conducted at Sheba Medical Center, a globally ranked hospital known for its innovation in translational research.
“We are pleased to report that the injection of Allocetra into the first patient’s TMJ was successfully completed with no complications,” said Dr. Einat Galamidi, Chief Medical Officer at Enlivex. “This study will provide a preliminary evaluation of the safety and potential effect of Allocetra for the treatment of TMJ osteoarthritis, which affects a joint that is critical for daily function.”
With dosing underway, Enlivex will continue monitoring participants for clinical response and tolerability, aiming to support future trials in larger patient populations and expand the platform’s application into degenerative joint conditions.
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