Allocetra Trial Yields Positive Interim Results for Knee Osteoarthritis Relief

Enlivex Therapeutics Ltd.’s knee osteoarthritis treatment helps reduce pain and improves joint functionality, according to interim efficacy data from its Phase I/II Allocetra trial.

The randomized, multi-country Phase I/II clinical trial consists of two stages. The first stage—now successfully completed—was a safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra injections to affected knees in order to identify the dose and injection regimen for the subsequent Phase II stage.

The company previously announced that no serious adverse reactions were reported during or following treatment in the Phase I stage. Detailed data from interim efficacy results are positive, statistically significant (p-value < 0.0007, n=12), and show marked improvements in all key efficacy endpoints, including reduction of pain and an improvement in functionality, compared to baseline, according to the company. The results are based on a three-month follow-up after treatment with Allocetra injections.

“Osteoarthritis is the most prevalent form of arthritis and is a leading cause of adult chronic pain and long-term disability, affecting more than 32.5 million Americans,” Enlivex Therapeutics Medical Vice President Einat Galamidi, M.D., said. “Currently there are no commercially available drugs proven to arrest or reverse progression of the disease. These interim results may indicate that the novel mechanism of action of Allocetra may provide a treatment alternative for these osteoarthritis patients.”

The trial is currently enrolling patients into the Phase II stage, which is a double-blind, randomized, placebo-controlled trial. In addition to evaluating safety, the blinded randomized stage is statistically powered to assess the efficacy of Allocetra knee injections. 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 post treatment.

Osteoarthritis⁵ 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 five to 15 years. Seventy-eight 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 more than 1 million U.S. hospitalizations annually, primarily for total joint replacement. There are currently no medications approved by either the U.S. Food and Drug Administration (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.

References
¹ Percent reduction calculated per patient and then averaged for all patients.
² Function and stiffness were assessed via Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire.
³ A lower score corresponds to higher function and lower stiffness, as applicable, and is indicative of a better response to treatment.
⁴ 75% of the patients were responders according to the OMERACT-OARSI criteria (Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International)
⁵ Source: The Arthritis Foundation, Disease modification in osteoarthritis; pathways to drug approval, Katz et. Al., Osteoarthritis and Cartilage Open (2) (2020)