Enlivex Gets Approval for Phase I/II Trial of Allocetra in Thumb Osteoarthritis

Enlivex Therapeutics Ltd. has received authorization from the Israeli Ministry of Health to begin a Phase I/II clinical trial to test the efficacy, safety, and tolerability of AllocetraTM for treating basal thumb joint osteoarthritis. This condition, affecting the carpometacarpal (CMC) joint of the thumb, is common, painful, and currently lacks effective long-term treatments approved by the FDA.

The trial is led by Dr. Amir Oron, a specialist in Orthopedics and the Chief of Hand Surgery and Microsurgery at the Kaplan Medical Center. Dr. Oron highlights the severe impact of thumb osteoarthritis and expresses optimism about Allocetra’s potential to modify the disease, given its innovative mechanism of action which reprograms macrophages, cells critical in the development and progression of osteoarthritis.

This trial marks the third study of AllocetraTM in osteoarthritis. Previous studies include ongoing trials in knee osteoarthritis both in pre-surgery, end-stage cases, and in up to 160 patients with moderate to severe symptoms.

The new trial will involve up to 46 patients and comprise two stages. The first stage is an open-label, dose-escalation phase to assess safety and tolerability, aiming to identify the appropriate dosage for the subsequent phase. The second stage is a double-blind, randomized, placebo-controlled stage. Up to 40 patients will be randomized in a 1:1 ratio to receive either AllocetraTM at the chosen dose or a placebo. The primary focus will be on monitoring adverse events, while secondary outcomes will measure changes in pain and function over 12 months.

Dr. Oren Hershkovitz, CEO of Enlivex, emphasized the importance of these trials in expanding the clinical development of AllocetraTM for treating osteoarthritis in various joints. He reiterated the company's commitment to advancing AllocetraTM as a novel therapy that could significantly enhance the lives of patients suffering from osteoarthritic conditions.

AllocetraTM is an off-the-shelf cell therapy designed to reprogram macrophages to restore their homeostatic state. This reprogramming is essential for managing diseases like sepsis and solid cancers, where macrophages contribute to the severity. By resetting these cells, AllocetraTM offers a new immunotherapeutic mechanism that could address various life-threatening medical needs, either as a standalone treatment or in combination with other therapies.

Basal thumb osteoarthritis is a chronic condition causing pain, stiffness, and sometimes swelling in the thumb’s base joint (CMC joint). It can make simple daily tasks painful and is more prevalent with age, particularly in postmenopausal women. A significant percentage of the adult population suffers from symptomatic thumb osteoarthritis, which worsens over time as conventional treatments lose their effectiveness. Currently, no effective long-term treatments exist for this debilitating disease.

Enlivex is at the forefront of developing AllocetraTM, aiming to rebalance the immune system by returning macrophages to their homeostatic state. This approach is critical for resolving severe conditions and improving patient outcomes.

This new study will provide valuable insights into the potential of AllocetraTM to offer a groundbreaking solution for thumb osteoarthritis, potentially modifying the disease and providing relief for millions of sufferers. The trial’s results could pave the way for expanding AllocetraTM's application to other osteoarthritic joints, aligning with Enlivex’s goal of delivering transformative therapies.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!