The trial aims to recruit six subjects who have not responded adequately to existing TMJ osteoarthritis treatments. Credit: sweet_tomato/Shutterstock.

Enlivex Therapeutics has gained approval from the Israeli Ministry of Health to commence a Phase I trial of Allocetra in individuals with temporomandibular joint (TMJ) osteoarthritis.

The study, to be conducted by Sheba Medical Center’s Rheumatology Unit in partnership with the Department of Oral and Maxillofacial Surgery, will explore the tolerability, preliminary efficacy, and safety of Allocetra injection.

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The trial aims to recruit six subjects who have not responded adequately to existing treatments for the given condition.

The primary safety endpoints of the study will include monitoring the severity and frequency of adverse and serious adverse events.

Efficacy endpoints are set to be evaluated by observing changes in TMJ pain, joint function, and other disease metrics for up to one year after receiving the therapy.

Enlivex Therapeutics CEO Dr Oren Hershkovitz 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.

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“Allocetra is currently being evaluated for other types of osteoarthritis and may provide a meaningful therapeutic option to alleviate this condition.”

A universal, off-the-shelf cell therapy, Allocetra is tailored to reset macrophages to their homeostatic state. Sepsis and solid cancers may cause macrophages to deviate from this state, exacerbating the severity of these conditions.

Allocetra’s ability to restore macrophage balance could represent a new immunotherapeutic approach for critical illnesses currently lacking effective treatments.

A degenerative joint disease, TMJ osteoarthritis, leads to the deterioration of the TMJ’s soft and hard tissues, causing pain and stiffness that can impede basic actions like chewing and yawning.

In April, the company reported positive topline safety and efficacy data from a Phase II trial of the therapy in individuals with sepsis.

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