Enlivex Receives Positive DSMB Nod to Start Phase II of Allocetra Trial for Knee Osteoarthritis

Nes-Ziona, Israel, Sept. 24, 2024 – Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage company focused on macrophage reprogramming immunotherapy, has announced that an independent Data and Safety Monitoring Board (DSMB) has completed an interim review of the Phase I stage of their ongoing Phase I/II clinical trial of Allocetra™. This trial involves up to 160 patients with moderate to severe knee osteoarthritis. During the Phase I safety run-in stage, patients received three escalating doses of Allocetra™ through sequential injections, and no serious adverse reactions were observed.

Following the review of the interim data, the DSMB confirmed the safety profile of Allocetra™, allowing Enlivex to proceed to the Phase II stage of the trial. This next phase is a double-blind, randomized evaluation of Allocetra™'s safety and efficacy, comparing intra-articular knee injections of the treatment to a placebo. Given the favorable safety data from Phase I, the DSMB has permitted the Phase II stage to use the highest dose tested during the initial phase.

The Phase I/II multi-center trial is divided into two parts. The first part, Phase I, is an open-label dose-escalation phase aimed at assessing the safety and tolerability of Allocetra™ injections in the target knee to identify the optimal dose and injection regimen for Phase II. The second part, Phase II, will be a double-blind, randomized, placebo-controlled phase. With the DSMB's confirmation, the company is now set to begin this phase, which is designed not only to continue evaluating safety but also to statistically measure the efficacy of Allocetra™ injections.

The primary focus for efficacy evaluation will be on joint pain and joint function compared to the placebo at three different intervals: three months, six months, and 12 months post-treatment.

Knee osteoarthritis is the most prevalent form of arthritis, impacting over 32.5 million Americans and exceeding 300 million people globally. Around half of the individuals who sustain ACL injuries develop osteoarthritis within 5 to 15 years. Projections estimate that by 2040, 78 million Americans will be living with osteoarthritis. Symptomatic knee osteoarthritis is notably common and debilitating, affecting 40% of men and 47% of women over their lifetimes. In the U.S., osteoarthritis results in over a million hospitalizations annually, primarily for total joint replacements. The disease's impact is tremendous, necessitating effective treatments to alleviate pain and disability.

Currently, no medications have been approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) that can arrest, slow, or reverse the structural damage caused by osteoarthritis.

Enlivex Therapeutics is engaged in developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. This reprogramming is essential for restoring immune balance and addressing severe and debilitating conditions.