Enlivex Reports Positive Interim Results from Allocetra Trial for Knee Osteoarthritis

Nes-Ziona, Israel, Dec. 03, 2024 - Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has unveiled promising interim efficacy data from the initial phase of its multi-national Phase I/II clinical trial for Allocetra™ in patients suffering from moderate to severe knee osteoarthritis. This clinical trial is divided into two stages, with the first phase already completed.

The initial stage, known as Phase I, was an open-label dose escalation phase aimed at assessing the safety and tolerability of Allocetra™ injections in the affected knee. This phase was crucial for determining the appropriate dose and injection regimen for the subsequent Phase II stage. Previously, the company stated that there were no serious adverse reactions during or after treatment in this phase.

The newly released interim efficacy data, gathered three months post-administration of Allocetra™ injections, reveals highly positive and statistically significant results (p-value < 0.0007, n=12). These results indicate substantial improvements in all primary efficacy endpoints, including pain reduction and enhanced functionality compared to baseline levels.

Key interim results include:

- Average knee joint pain, measured on a scale from 0 (no pain) to 10 (maximum pain), decreased from 6.10 pre-treatment to 2.94 three months post-treatment, reflecting a 50% reduction (p<0.0007).
- The range of pain within the group shifted from a median of 4.71 – 8.20 (5.43) pre-treatment to 0.14 – 6.29 (2.49) post-treatment.
- Average knee joint function, on a scale from 0 to 10, improved from 4.7 to 2.83, a 42% enhancement (p<0.0008).
- Average knee joint stiffness decreased from 5.4 to 3.23, marking a 37% reduction (p<0.003).

Additionally, 83% of patients treated with Allocetra™ experienced more than a 40% reduction in pain after three months, compared to 17% in the non-responder group.

Dr. Einat Galamidi, Medical Vice President of Enlivex, highlighted the significance of these findings for treating osteoarthritis, the most common form of arthritis. Affecting over 32.5 million Americans, osteoarthritis is a major source of chronic pain and long-term disability. Dr. Galamidi emphasized that there are currently no drugs available that can halt or reverse the disease’s progression, and these interim results suggest that Allocetra™ may offer a new treatment option for osteoarthritis patients.

The trial is now advancing to the Phase II stage, which will be a double-blind, randomized, placebo-controlled trial. This phase aims to further evaluate the safety and efficacy of Allocetra™ injections in the knee. Key efficacy endpoints will include joint pain and functionality comparisons to placebo at three, six, and twelve months post-treatment.

Knee osteoarthritis is a widespread and debilitating condition, with significant prevalence among both men and women. By 2040, it is estimated that 78 million Americans will be affected by osteoarthritis, underlining the pressing need for effective treatments. Current treatments do not stop or reverse joint damage, making the development of new therapies such as Allocetra™ essential.

Enlivex Therapeutics Ltd. is at the forefront of macrophage reprogramming immunotherapy, focusing on developing Allocetra™, an off-the-shelf cell therapy designed to reset macrophages to their homeostatic state. This reprogramming is vital for rebalancing the immune system and resolving severe and debilitating conditions.

For more details about Enlivex and its innovative therapies, visit their website.