Enlivex Gets Danish Green Light for Phase II Allocetra Trial in Knee Osteoarthritis

Nes-Ziona, Israel, Sept. 26, 2024 – Enlivex Therapeutics Ltd. has announced that the Danish Medicines Agency has granted permission to proceed with the Phase II stage of their multi-country Phase I/II trial aimed at treating moderate and severe knee osteoarthritis. This decision comes after the independent Data and Safety Monitoring Board (DSMB) recently recommended that the trial move forward to the next phase.

The trial, which spans multiple centers, is structured in two main phases. The initial Phase I segment is a safety run-in, open-label dose escalation stage. This phase focuses on assessing the safety and tolerability of Allocetra™ injections in the affected knee, determining the appropriate dosage and injection schedule for the subsequent Phase II stage. The Phase II segment is a double-blind, randomized, placebo-controlled phase, which Enlivex is initiating following the successful completion of the Phase I safety run-in and subsequent DSMB safety confirmation. The primary objective in the Phase II stage is to evaluate the efficacy of Allocetra™ injections in the knee. Key measurements will focus on joint pain and function compared to a placebo over a timeline of three, six, and twelve months post-treatment.

Enlivex's Medical Vice President, Dr. Einat Galamidi, expressed satisfaction with the results thus far, stating, “We are pleased with the safety profile of Allocetra™ following three sequential intra-articular knee injections, as demonstrated in the first twelve patients in the Phase I safety run-in stage of this trial, and the approval to progress into the double-blind, randomized, placebo-controlled Phase II stage.”

Knee osteoarthritis is a widespread form of arthritis, impacting over 32.5 million Americans and more than 300 million people globally. It often develops in knees that have previously sustained ACL injuries, with nearly half of such cases progressing to osteoarthritis within 5 to 15 years. Projections estimate that by 2040, around 78 million Americans will suffer from osteoarthritis. This condition is notably common and debilitating, affecting 40% of men and 47% of women during their lifetimes. In the U.S., over one million hospitalizations annually are attributed to osteoarthritis, predominantly for total joint replacements. Given the significant burden of osteoarthritis, effective treatments that alleviate pain and reduce disability are urgently needed. Currently, there are no FDA or EMA-approved medications that can halt, slow, or reverse the structural damage associated with osteoarthritis.

Enlivex is dedicated to developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. By resetting non-homeostatic macrophages, Allocetra™ aims to rebalance the immune system and address life-threatening and debilitating conditions.

Enlivex Therapeutics Ltd. is a clinical-stage company focusing on macrophage reprogramming immunotherapy. The company's primary product, Allocetra™, aims to reset macrophages to their homeostatic state, which is crucial for immune system balance and the resolution of severe health conditions.