Enlivex Receives Regulatory Authorization for the Initiation of a Placebo-Controlled Phase I/II Trial Evaluating Allocetra in Up To 46 Patients with Thumb Osteoarthritis

Core Insights - Enlivex Therapeutics has received authorization from the Israeli Ministry of Health to initiate a Phase I/II trial for Allocetra™ targeting thumb osteoarthritis, a condition with no FDA-approved therapies [1][4] - The trial will be led by Dr. Amir Oron, focusing on the role of macrophages in osteoarthritis and the potential of Allocetra™ as a disease-modifying treatment [2][4] - Allocetra™ is designed to reprogram macrophages into their homeostatic state, potentially addressing unmet medical needs in various diseases [5][8] Company Overview - Enlivex Therapeutics is a clinical-stage company specializing in macrophage reprogramming immunotherapy, with Allocetra™ as its primary product [8] - The company aims to develop novel therapies that can improve the quality of life for patients suffering from osteoarthritic conditions [4] Trial Details - The Phase I/II trial will recruit up to 46 patients, consisting of a safety run-in phase followed by a randomized, placebo-controlled stage [3] - The primary safety endpoint will assess adverse events, while efficacy will be measured through changes in pain and function over 12 months [3] Disease Context - Basal thumb osteoarthritis is a chronic condition that significantly impacts daily activities, with a prevalence of 5.8% in 50-year-old males and 7.3% in females, increasing to 33.1% and 39.0% in those aged 80 [6][7] - Current treatments for thumb osteoarthritis are limited, and the condition often progresses despite conservative management [7]