Enlivex Begins Phase I/II Trial of AllocetraTM for Thumb Osteoarthritis

Enlivex Therapeutics Ltd. (Nasdaq: ENLV), an innovative company specializing in macrophage reprogramming immunotherapy, has initiated the first dosing of a patient in a Phase I/II clinical trial for its new treatment, AllocetraTM. This investigational therapy is targeted at basal thumb joint osteoarthritis, a severe and progressive condition that currently lacks effective long-term treatments approved by the FDA.

The Phase I/II trial is designed to examine both the safety and efficacy of AllocetraTM when injected into the basal thumb joint. The trial will enroll up to 46 patients and is divided into two stages. The initial stage is an open-label, dose-escalation phase aimed at determining the safety and tolerability of AllocetraTM. This phase will identify the appropriate dose for the subsequent randomized stage. Following this, the second stage will be a double-blind, randomized, placebo-controlled trial. In this segment, 40 patients will be randomly assigned in a 1:1 ratio to receive either the selected dose of AllocetraTM or a placebo. The primary endpoints for safety will assess the frequency and severity of any adverse events, while the efficacy will be measured through changes in pain and function over a 12-month period.

CEO of Enlivex, Oren Hershkovitz, Ph.D., expressed satisfaction with the rapid initiation of patient enrollment soon after regulatory approval. He confirmed that the first injection was completed successfully without any complications.

AllocetraTM is positioned as a universal, off-the-shelf cell therapy, designed to return macrophages to their homeostatic state. Various diseases, including solid cancers and sepsis, disrupt this state, exacerbating disease severity. Reprogramming macrophages back to their balanced state could offer a novel immunotherapeutic approach for numerous severe and debilitating conditions, which are currently unmet medical needs.

Basal thumb osteoarthritis is a chronic condition characterized by pain, stiffness, and swelling in the joint at the thumb's base. This condition can make everyday tasks challenging and painful. The likelihood of developing basal thumb osteoarthritis increases with age and is more prevalent among postmenopausal women. Studies indicate that the prevalence of thumb osteoarthritis is about 5.8% for 50-year-old males and 7.3% for females of the same age, escalating to 33.1% in males and 39.0% in females by the age of 80. Overall, symptomatic prevalence is estimated to affect up to 15% of adults over the age of 30. Unfortunately, as the disease progresses, conventional treatments and anti-inflammatory medications become less effective, underlining the need for new therapeutic solutions like AllocetraTM.

Enlivex Therapeutics Ltd. continues to focus on developing AllocetraTM, with the aim of reprogramming macrophages to restore immune system balance and tackle life-threatening conditions.