• 15 Apr 2024
• Admin
• News Article

Enlivex Announces Positive Results from Phase II Trial of Allocetra

Enlivex announces positive results from phase II trial of Allocetra in patients with sepsis

Overview

Enlivex Therapeutics Ltd., a clinical-stage macrophage reprogramming immunotherapy company, announced positive indication of effect and safety results from its phase II study of Allocetra in patients with sepsis, in which 120 patients enrolled.

Words from an Expert: Clincal Investigator

• Bruno François, M.D., intensive care physician, is the head of the Limoges Clinical Investigation Center (Limoges, France). Dr. François took a primary role in the design of the study, medical support and oversight of patient eligibility. 
• Dr. François was the national coordinator for numerous emergency trials, especially in sepsis, and has participated in several advisory boards for sepsis multinational trials, independent clinical evaluation committees and adjudication committees. 
• Dr. François stated, ""I am very excited about Allocetra's novel approach, using a first-in-class innovative cell therapy to explore the treatment of patients with acute, life-threatening sepsis and septic shock. The study, a randomized controlled trial conducted in six countries and multiple clinical centers, demonstrated a favourable safety profile for Allocetra. Within the context of the study, we also learned the ease of use and feasibility to infuse Allocetra cells to patients even in the complex setting of the intensive care unit. The study was well designed and executed, although randomization resulted in the Allocetra-treated cohorts having higher frequencies of septic shock and invasive ventilation prior to treatment, as compared with the control group.”
• “Because these patient attributes are typically associated with a significantly higher degree of difficulty of treatment and higher mortality rates, the relative effect of Allocetra in some patient sub populations was challenging to deduce. I am pleased with the unusually low mortality rates across the board in the study, and that Allocetra demonstrated a potential indication of effect in high-risk sepsis patients originating from urinary tract infections.”
• “A substantial number of sepsis cases originate from urinary tract infections, and we have been actively searching for additional treatment alternatives for those patients, especially those who are at high risk. Having reviewed the topline study results, I look forward to reviewing the forthcoming additional safety and biomarker data of patients in the study, and I recommend the further exploration of the use of Allocetra in the High Risk UTI population."

Words from CEO: Enlivex

• Oren Hershkovitz, Ph.D., CEO of Enlivex said, We are pleased with the demonstration of substantial SOFA score reductions and low mortality rate of the Allocetra-treated patients across all origins of sepsis in the study, the indication of effect compared with placebo for the high-risk patients whose sepsis originated from urinary tract infections, and the favourable safety profile of Allocetra. 
• The company intends to consider, upon reviewing the totality of the data, a potential follow-on, randomized, controlled study of a solely High Risk UTI sepsis population. Up to 31% of sepsis cases start as UTIs4, and this represents a substantial potential market opportunity for Allocetra. The randomization resulted in the Allocetra-treated cohorts having 20% higher frequency of septic shock and 35% higher frequency of invasive ventilation prior to treatment, compared with the placebo group. 
• Both of these patient attributes are associated with significantly higher degree of difficulty of treatment and higher mortality rates, and potentially resulted in patients with more severe sepsis in the Allocetra-treated cohorts. These biases made it challenging to deduce the relative effect in other patient subgroups.

Urinary Tract Infection

• Urinary tract infection (UTI) is the second most common infectious disease affecting more than 150 million people globally annually. 
• Up to 31% of sepsis cases start as UTIs, representing up to 9.8 million cases in the United States and Europe, leading to as many as 1.6 million deaths.

Phase II Trial

• The phase II trial was a placebo-controlled, randomized, dose-finding, multi-country, multi-centre study, evaluating frozen-formulation Allocetra in addition to standard of care in patients with sepsis associated with pneumonia, biliary, urinary tract, or peritoneal infections. 
• The results contained in this press release represent topline data and are subject to revision based on the ongoing collection of study information and detailed analysis. 
• The company expects to release further details about the study in a forthcoming presentation.

Allocetra

• Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. 
• Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. 
• These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. 
• By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as ""unmet medical needs"", as a stand-alone therapy or in combination with leading therapeutic agents.

About Enlivex

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.