Enlivex Announces Enrollment & Dosing of the First 10 Patients in the Randomized Phase 2 Stage of its Allocetra Trial

Enlivex Therapeutics Ltd. recently announced the enrollment and dosing of the first 10 patients in the randomized Phase 2 stage of the company’s multi-country Phase 1/2 Allocetra trial in patients with moderate-to-severe knee osteoarthritis. The initiation of patient dosing follows the recently announced recommendation by the independent Data and Safety Monitoring Board to proceed with the randomized Phase II stage at the highest tested dose, as well as the Danish Medicines Agency’s authorization to initiate this next trial stage.

The multi-center Phase 1/2 clinical trial consists of two stages. The first stage, which was successfully completed, was a Phase I safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra injections to the target knee in order to identify the dose and injection regimen for the subsequent Phase 2 stage. The Phase 2 stage is a double-blind, randomized, placebo-controlled stage. In addition to evaluating safety, the blinded randomized stage is statistically powered to assess the efficacy of Allocetra injections into the knee. The trial’s key efficacy end points will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months after treatment.

Einat Galamidi, MD, Medical Vice President of Enlivex, said “We are highly committed to executing our clinical programs in accordance with our projected timelines. The first 10 patients in the double-blind, randomized, placebo-controlled Phase 2 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.”

Osteoarthritis is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACL injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomatic knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes. Osteoarthritis accounts for over one million hospitalizations annually in the United States, primarily for total joint replacement. The burden of osteoarthritis is enormous, and the need for treatments that reduce pain and attendant disability for persons with osteoarthritis is critical. There are currently no medications approved by either the US FDA or the European Medicines Agency (EMA) that have been demonstrated to arrest, slow or reverse progression of structural damage in the joint.

Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra, 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. For more information, visit https://enlivex.com/.