Enlivex Therapeutics' Allocetra has received authorization from the Danish Medicines Agency to proceed to Phase II clinical trials for the treatment of moderate to severe knee osteoarthritis. This decision follows a positive recommendation from the independent Data and Safety Monitoring Board (DSMB), based on the safety data from the Phase I safety run-in stage of the trial.
The Phase I/II trial is a multi-center study composed of two stages. The first stage, a Phase I safety run-in, was an open-label dose escalation phase designed to characterize the safety and tolerability of Allocetra injections into the knee and to identify the optimal dose and injection regimen for Phase II. The Phase II stage is a double-blind, randomized, placebo-controlled study designed to evaluate both the safety and efficacy of Allocetra.
Phase I Safety Results
The Phase I safety run-in involved twelve patients who received three sequential intra-articular knee injections of Allocetra at escalating doses. According to Enlivex, no serious adverse reactions were reported during or following the treatment. This positive safety profile led the DSMB to recommend proceeding to Phase II, utilizing the highest dose of Allocetra tested in Phase I.
Einat Galamidi, MD, Medical Vice President of Enlivex, commented, "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."
Phase II Trial Design
The Phase II trial will evaluate the safety and efficacy of Allocetra injections into the knee, with primary measurements assessing joint pain and joint function compared to placebo at three, six, and twelve months post-treatment. The trial is statistically powered to assess the efficacy of Allocetra injections into the knee.
About Knee Osteoarthritis
Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and more than 300 million individuals worldwide. Symptomatic knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes. There are currently no medications approved by the FDA or EMA that have been demonstrated to arrest, slow, or reverse progression of structural damage in the joint.
Allocetra: A Novel Immunotherapy Approach
Enlivex is developing Allocetra as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening and life debilitating conditions. As a macrophage reprogramming immunotherapy, Allocetra represents an innovative approach to treating osteoarthritis, potentially addressing underlying inflammatory processes.
