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Enlivex Therapeutics Ltd., a clinical-stage macrophage reprogramming immunotherapy company, announced that the China National Intellectual Property Administration (CNIPA) issued a notice of allowance for patent application number 2020800620493. Once issued, the resulting patent will provide Enlivex with added intellectual property protection in China through at least 2040 with claims covering methods of using Allocetra to treat subjects with osteoarthritis. The Company expects that this new patent will be issued in China during the first half of 2025.
Enlivex recently reported positive interim six (6) months efficacy data from the first stage of its ongoing randomized, multi-country phase I/II Allocetra trial in patients with moderate to severe knee osteoarthritis.
Key highlights: Statistically significant, 47.0% average reduction of reported pain (P=0.0001), compared to average pain level at baseline; 46% improvement in joint function and 40% improvement in joint stiffness; 83% of the patients were still considered as responders to treatment1 after 6 months; No serious adverse events; Efficacy continues to display strong persistence and durability over time, maintaining the 3-month positive effect.
Oren Hershkovitz, Ph.D, CEO of Enlivex, commented, “We are very pleased to receive the first patent allowance for the use of Allocetra as a potential treatment in patients with osteoarthritis. We believe that this allowance provides high assurance that similar patent allowances will be obtained across 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 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 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.
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