Core Viewpoint - Enlivex Therapeutics Ltd. has received authorization from the Israeli Ministry of Health to initiate a Phase I trial for Allocetra™ in patients with temporomandibular joint (TMJ) osteoarthritis, aiming to evaluate its safety, tolerability, and initial efficacy [1][3]. Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal, off-the-shelf cell therapy designed to restore macrophages to their homeostatic state [4][6]. - The company aims to address unmet medical needs in various conditions, including solid cancers and sepsis, by reprogramming non-homeostatic macrophages [4][6]. Industry Context - TMJ disorders are the second most common musculoskeletal condition, affecting 5% to 12% of the global population, with an estimated annual health cost of $4 billion [5]. - TMJ osteoarthritis is the most prevalent form of arthritis in the TMJ, leading to significant pain and functional impairment, and currently lacks effective long-term treatment options [5]. Clinical Trial Details - The Phase I trial will be conducted by the Rheumatology Unit at Sheba Medical Center, which is recognized among the top 10 hospitals globally [2]. - The trial aims to recruit six patients who have not responded adequately to conventional treatments, with primary endpoints focusing on safety and secondary endpoints assessing pain and joint functionality over 12 months [3].
Enlivex Receives Regulatory Authorization for the Initiation of a Phase I Trial Evaluating Allocetra in Patients with TMJ Osteoarthritis