Enlivex Receives Regulatory Authorization for the Initiation of a Phase 1 Trial Evaluating Allocetra in Patients With TMJ Osteoarthritis

Enlivex Therapeutics Ltd. recently announced the Israeli Ministry of Health authorized the initiation of an investigator-initiated Phase 1 trial to evaluate the safety, tolerability, and initial efficacy of Allocetra for injection into the temporomandibular joint (TMJ) in patients suffering from TMJ osteoarthritis.

The study will be conducted by the Rheumatology Unit at Sheba Medical Center in collaboration with the Department of Oral and Maxillofacial Surgery. Notably, Sheba Medical Center was recently ranked among the top 10 hospitals in the world by Newsweek.

Dr. Oren Hershkovitz, CEO of Enlivex, said “TMJ osteoarthritis is a unique disease that can affect young, otherwise healthy individuals, causing substantial pain and impairment in oral function. In many cases, existing therapies fail to provide long-term relief, forcing patients to undergo multiple surgeries as their disease progresses. Allocetra is currently being evaluated for other types of osteoarthritis and may provide a meaningful therapeutic option to alleviate this condition.”

The Phase 1 trial aims to recruit six patients who have shown insufficient response to conventional treatments for TMJ osteoarthritis. The primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and efficacy endpoints will assess changes from baseline in TMJ pain, joint functionality, and other disease parameters for up to 12 months following administration of Allocetra.

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as “unmet medical needs,” as a stand-alone therapy or in combination with leading therapeutic agents.

Temporomandibular Joint (TMJ) disorders are the second most common musculoskeletal condition affecting 5 to 12% of the population globally, with an annual health cost estimated at $4 billion. Osteoarthritis of the TMJ is the most common form of arthritis in the TMJ, causing pain and stiffness in the jaw. It may become difficult to chew or yawn due to painful and stiff jaw muscles. TMJ osteoarthritis is a degenerative disease of the joint, which culminates in the progressive destruction of all soft and hard tissue components of the TMJ. In patients who present in early adulthood with severe clinical symptoms and catastrophic radiographic changes, there are significant implications for management, including the potential need for early total joint replacement. There are currently no effective long-term treatments for this disease.

Enlivex is a clinical-stage macrophage reprogramming immunotherapy company developing Allocetra, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit http://www.enlivex.com.