Enlivex Therapeutics Ltd. has announced the enrollment and dosing of the first 10 patients in the randomized Phase II stage of its multi-country Phase I/II Allocetra™ trial for patients with moderate to severe knee osteoarthritis. This follows the Data and Safety Monitoring Board's recommendation to proceed with the Phase II stage at the highest tested dose, and authorization from the Danish Medicines Agency.
The Phase I/II clinical trial consists of two stages. The first stage, a Phase I safety run-in, was an open-label dose escalation phase to characterize the safety and tolerability of Allocetra™ injections into the target knee, identifying the dose and injection regimen for Phase II. The Phase II stage is a double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of Allocetra™ injections into the knee. The trial will assess joint pain and function compared to placebo at three, six, and 12 months after treatment.
"We are highly committed to executing our clinical programs in accordance with our projected timelines," said Einat Galamidi, MD, Medical Vice President of Enlivex. "The first 10 patients in the double-blind, randomized, placebo-controlled Phase II stage of the study successfully started their course of intra-articular knee injections. No safety concerns were recorded following the initial dosing. Osteoarthritis is the most prevalent form of arthritis and is a leading cause of adult chronic pain and long-term disability. Currently there are no commercially available drugs proven to arrest or reverse progression of this disease, and we are hopeful that the novel mechanism of action of Allocetra™ will change the way we treat these patients."
Knee Osteoarthritis: A Significant Unmet Need
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, with 40% of men and 47% of women developing it in their lifetimes. Osteoarthritis accounts for over one million hospitalizations annually in the United States, primarily for total joint replacement. There are currently no FDA or EMA-approved medications demonstrated to arrest, slow, or reverse structural damage in the joint.
About Allocetra™
Enlivex is developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages is critical for immune system rebalancing and resolution of life-threatening and debilitating conditions.
