IMOH Approves Enlivex's Multi-Country Phase I/II Trial for Allocetra in Knee Osteoarthritis

Enlivex Therapeutics, a company at the forefront of clinical-stage immunotherapy, is advancing its innovative approach to treating osteoarthritis with a focus on macrophage reprogramming. The Israeli Ministry of Health has granted approval for a multi-country Phase I/II clinical trial, which will assess the efficacy, safety, and tolerability of Allocetra™, a novel therapy designed to restore macrophages to their balanced state.

The trial is structured in two phases, beginning with an open-label dose escalation to determine the appropriate dosage and injection protocol for Allocetra™. Following this initial stage, a randomized, double-blind, placebo-controlled phase will commence, which is expected to involve up to 160 patients suffering from moderate to severe osteoarthritis. The primary outcomes will measure improvements in joint pain and function over a period of 12 months.

Macrophages, key immune cells, have emerged as a significant target in osteoarthritis treatment. They are believed to play a crucial role in disease progression, and by reprogramming them, Allocetra™ may offer a promising therapeutic intervention. The therapy aims to address the substantial patient population affected by moderate to severe osteoarthritis, a condition that significantly impacts quality of life.

Enlivex's CEO, Oren Hershkovitz, highlighted the significance of the Israeli Ministry of Health's approval, emphasizing the company's commitment to advancing the osteoarthritis development program. The trial's design, with its emphasis on a blinded, randomized controlled study, underscores the rigorous scientific approach Enlivex is taking to evaluate Allocetra™.

Allocetra™ represents a universal cell therapy that has the potential to reprogram macrophages, which are often deranged in diseases such as cancer and sepsis. By restoring their homeostatic state, Allocetra™ could offer a new immunotherapeutic mechanism for treating serious conditions characterized by unmet medical needs. The therapy is positioned as a standalone or adjunct treatment alongside existing therapies.

Enlivex Therapeutics is dedicated to the development of macrophage reprogramming therapies, with a focus on rebalancing the immune system to resolve life-threatening conditions. The company's mission is to provide innovative solutions that address critical unmet needs in healthcare.
It is important to note that the development of new therapies involves inherent risks and uncertainties. Clinical trials may not always yield the expected results, and the path to regulatory approval can be complex and unpredictable. However, the potential benefits of therapies like Allocetra™ underscore the importance of continued research and development in the field of immunotherapy.