Enlivex Announces Issuance of New Patent Application Covering the Use of Allocetra in Patients With Osteoarthritis

Enlivex Therapeutics Ltd. recently announced the issuance of an Israeli patent, numbered 290470, titled THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS. The patent will provide Enlivex with added intellectual property protection in Israel through at least 2040 with claims covering methods of using Allocetra to treat subjects with osteoarthritis.

Enlivex recently reported positive three-month topline data from the Phase 2a stage of ENX-CL-05-001, a multi-center, two-stage Phase 1/2 double-blind, randomized, placebo-controlled clinical trial evaluating Allocetra in patients with moderate-to-severe knee osteoarthritis.

In the overall modified intention-to-treat (mITT) population, improvements across all efficacy and secondary endpoints, including 24% reduction in knee pain and 26% improvement in knee function, were observed in the Allocetra treatment arm vs placebo; moreover, 72% reduction in knee pain and 109% improvement in knee function were observed for age-related primary osteoarthritis patients compared with placebo – a substantial, clinically meaningful and statistically significant effect in commonly used Phase 3 primary endpoints for knee osteoarthritis clinical trials.

Oren Hershkovitz, PhD, CEO of Enlivex, said “We are very pleased to receive another patent issuance for the use of Allocetra as a potential treatment in patients with osteoarthritis. We believe that this issuance provides high assurance that we will be able to obtain similar patents in all major jurisdictions as part of our IP portfolio rollout.”

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 US, 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 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. For more information, visit https://enlivex.com/.