Enlivex Completes Enrollment for Phase II Trial of Allocetra in Knee Osteoarthritis

On April 21, 2025, Enlivex Therapeutics Ltd. announced the completion of patient enrollment in the Phase II stage of its Phase I/II clinical trial for Allocetra™, targeting moderate to severe knee osteoarthritis. This trial involves 133 patients in its second phase and evaluates the efficacy and safety of Allocetra™, a macrophage reprogramming immunotherapy designed to treat osteoarthritis.

CEO Oren Hershkovitz expressed satisfaction with the progress, referencing promising results from the initial Phase I stage. The company anticipates releasing the 3-month topline data by August 2025, with hopes that Allocetra™ could revolutionize current osteoarthritis treatments.

The clinical trial is conducted across multiple centers and consists of two stages. The initial Phase I stage was an open-label dose escalation trial to determine the optimal dosage and injection regimen, focusing on safety and tolerability. Encouraging interim results showed significant improvements in key efficacy endpoints without safety concerns.

Following this, the Phase II stage is a double-blind, randomized, placebo-controlled trial. Besides safety assessments, the trial includes an interim analysis by an independent third party, evaluating the necessity of increasing the participant count beyond the initially planned sample size. This analysis considers the statistical impact on the overall and subgroup analyses. The study also features a Data Safety and Monitoring Board (DSMB) that periodically reviews safety data.

Key efficacy endpoints of the trial include assessments of joint pain and function at various intervals: three months, six months, and post-treatment, extending to a 12-month follow-up. The company expects to report the Phase II topline data, including all 3-month endpoints, by August 2025.

Osteoarthritis is the most prevalent form of arthritis, affecting over 32.5 million Americans and more than 300 million people worldwide. It is common among individuals with ACL injuries, with about half developing osteoarthritis within 5 to 15 years post-injury. By 2040, approximately 78 million Americans are expected to have osteoarthritis. Particularly, knee osteoarthritis is widespread and disabling, affecting 40% of men and 47% of women during their lifetimes. Annually, osteoarthritis accounts for over a million hospitalizations in the United States, primarily for joint replacements. The condition poses a significant burden, highlighting the urgent need for treatments that alleviate pain and disability, as current medications approved by the FDA or EMA do not halt or reverse joint damage progression.

Enlivex Therapeutics is at the forefront of developing Allocetra™, a ready-to-use cell therapy aimed at reprogramming macrophages to their natural state. This process is crucial for rebalancing the immune system and resolving severe health conditions.

The potential of Allocetra™ to address the substantial unmet need in osteoarthritis treatment is significant, with Enlivex continuing its efforts to bring this innovative therapy to patients globally.