Enlivex Reports Positive Interim Data from Allocetra Trial in End-Stage Knee Osteoarthritis

Enlivex Therapeutics Ltd. has revealed promising interim results from their Phase I/II clinical trial of AllocetraTM for patients with severe knee osteoarthritis. This trial involves patients who were recommended knee replacement surgery but instead received a single injection of AllocetraTM into the knee. This step aims to alleviate pain and improve knee functionality as a potential alternative to surgery.

Nine patients participated in the trial, each receiving one AllocetraTM injection and being monitored over a three-month period. Pain levels were gauged on a scale from zero (no pain) to ten (maximum pain). The results were notable, showing an average pain reduction of 64% from the initial baseline. Furthermore, 89% of the patients experienced an improvement in knee pain, and 33% of participants reported complete pain relief, dropping from an average pain level of nine to zero.

A significant outcome was that 89% of these patients chose not to proceed with knee replacement surgery after three months. Only one patient decided to go ahead with the surgery, indicating the potential of AllocetraTM as a viable alternative to surgery. Importantly, no severe adverse events related to AllocetraTM were reported, underscoring its favorable safety profile.

The trial, led by Dr. Amir Oron, a senior specialist in Orthopedics and Chief of Hand Surgery and Microsurgery at Kaplan Medical Center, highlights the potential of AllocetraTM. Dr. Oron expressed satisfaction with the interim results, emphasizing the need for better treatment options for patients with severe knee osteoarthritis. These patients have often exhausted other treatments without lasting improvement, and AllocetraTM offers a promising new alternative.

Dr. Einat Galamidi, Vice President of Medical at Enlivex, noted that this is the first instance of AllocetraTM being used as a localized joint injection, building on previous systemic infusion studies. She highlighted that these findings confirm the safety of AllocetraTM when used locally and open avenues for its therapeutic use in joint diseases with inflammatory components.

The trial is ongoing, aiming to enroll a total of 18 patients. Participants will receive a single AllocetraTM injection in the affected knee and will be monitored for safety, pain reduction, and functional improvements for up to 12 months post-injection.

AllocetraTM is a universal off-the-shelf cell therapy developed to reprogram macrophages into their homeostatic state, which is crucial for immune balance. By restoring macrophage homeostasis, AllocetraTM has shown potential to offer a novel immunotherapeutic approach for various diseases, including solid cancers and sepsis.

Knee osteoarthritis, the focus of this trial, is the most common form of arthritis worldwide, affecting over 300 million people. In the United States alone, osteoarthritis leads to over a million hospitalizations annually, primarily for total joint replacements. The condition is particularly debilitating, with a substantial portion of the population developing it over their lifetimes. Currently, there are no approved medications to halt or reverse the structural damage caused by osteoarthritis, making the need for effective treatments critical.

Enlivex Therapeutics Ltd. continues to develop AllocetraTM, aiming to address significant unmet medical needs through innovative immunotherapy solutions. The positive interim results from this trial suggest a promising future for AllocetraTM in the treatment of knee osteoarthritis and potentially other inflammatory joint diseases.