Core Insights - Enlivex Therapeutics has completed patient enrollment for the Phase II stage of its clinical trial for Allocetra™ in treating moderate to severe knee osteoarthritis, involving a total of 133 patients [1][2][3] - The company aims to release topline data by August 2025, following promising initial efficacy results from the Phase I stage [2][3] Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, which is designed to restore macrophages to their homeostatic state [5] - The company emphasizes the potential of Allocetra™ to transform osteoarthritis treatment, addressing a significant unmet medical need [2][4] Clinical Trial Details - The Phase I/II trial consists of a safety run-in and a double-blind, randomized, placebo-controlled Phase II stage, with an independent data safety and monitoring board overseeing safety evaluations [3] - Positive interim results from the Phase I stage showed significant improvements in key efficacy endpoints without safety issues [3] Osteoarthritis Context - Osteoarthritis affects over 32.5 million Americans and more than 300 million people globally, with projections indicating that 78 million Americans will have the condition by 2040 [4] - The disease leads to significant healthcare burdens, including over one million hospitalizations annually in the U.S. for joint replacements, highlighting the critical need for effective treatments [4]

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to their homeostatic state [5]. Clinical Trial Progress - The company has completed patient enrollment for the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis, involving a total of 133 patients [1][3]. - The Phase I stage provided promising initial efficacy data, with significant improvements in key efficacy endpoints and no safety issues reported for the first 12 patients treated [2][3]. Future Expectations - Enlivex aims to release topline data from the Phase II trial, including full 3-month endpoints, by August 2025 [2][3]. Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and more than 300 million individuals globally, with projections indicating that 78 million Americans will have osteoarthritis by 2040 [4]. - The condition leads to significant healthcare burdens, with over one million hospitalizations annually in the U.S. primarily for total joint replacement, highlighting the critical need for effective treatments [4].

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, specifically developing Allocetra™ [1][6] - Allocetra™ is designed as a universal, off-the-shelf cell therapy aimed at restoring macrophage homeostasis, which is critical for immune system balance and addressing life-threatening conditions [4][6] Clinical Trial Announcement - The first patient has been dosed in a Phase I trial to evaluate the safety, tolerability, and initial efficacy of Allocetra™ for treating temporomandibular joint (TMJ) osteoarthritis [1][3] - The trial is being conducted by the Rheumatology Unit and the Department of Oral and Maxillofacial Surgery at Sheba Medical Center, which is ranked among the top 10 hospitals globally [2] Trial Details - The trial aims to recruit six patients who have not adequately responded to conventional therapies for TMJ osteoarthritis [3] - Primary safety endpoints will measure the frequency and severity of adverse events, while efficacy endpoints will assess changes in TMJ pain, joint functionality, and other disease parameters over 12 months [3] TMJ Osteoarthritis Insights - TMJ disorders affect 5% to 12% of the global population, with an annual health cost estimated at $4 billion [5][8] - TMJ osteoarthritis is the most common form of arthritis in the TMJ, leading to pain and stiffness, and currently lacks effective long-term treatments [5][8]

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to their homeostatic state [4]. Patent and Intellectual Property - The China National Intellectual Property Administration (CNIPA) has issued a notice of allowance for Enlivex's patent application number 2020800620493, which will provide intellectual property protection in China until at least 2040 for methods using Allocetra™ to treat osteoarthritis [1]. - The company anticipates that the patent will be officially issued in the first half of 2025 [1]. Clinical Trial Results - Enlivex reported positive interim data from a Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis, showing a statistically significant average pain reduction of 47.0% (P=0.0001) compared to baseline [6]. - The trial also indicated a 46% improvement in joint function and a 40% improvement in joint stiffness, with 83% of patients still considered responders after six months [6]. Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and more than 300 million people globally, with projections indicating that 78 million Americans will have the condition by 2040 [3]. - The disease leads to significant healthcare burdens, including over one million hospitalizations annually in the U.S. for total joint replacement, highlighting the critical need for effective treatments [3].