Enlivex Announces Topline Results Of Its Phase II Trial Evaluating Allocetra In Patients With Sepsis

Author: Benzinga Newsdesk | April 11, 2024 08:18am

• Analysis of eligible1 patients from the sepsis Phase II study (NCT# NCT04612413)
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    • In accordance with the study protocol, the safety and efficacy topline analysis includes sequential organ failure assessment (SOFA) scores and mortality for the 28-day period post treatment.
    • Efficacy:
      • Stand-alone analysis of the Allocetra™-treated patients, of which 78% had septic shock and 65% had invasive ventilation at screening, demonstrated substantial reductions in SOFA scores and 65% reduction in overall mortality rate as compared with expected mortality2.  By day 28, the analysis showed 90% reductions of SOFA scores for sepsis patients whose infection source was urinary tract, 68% for patients whose infection source was community-acquired pneumonia, and 36% for patients whose infection source was internal abdominal infection.
      • Relative analysis demonstrates a potential indication of effect of Allocetra™ as compared with placebo in high-risk, severe sepsis patient population (organ failure scores >=7), originating from urinary tract infections ("High Risk UTI"). Enlivex intends to consider a potential follow-on, randomized, controlled study of a solely High Risk UTI sepsis population. Up to 31% of sepsis cases start as urinary tract infections, representing up to 9.8 million cases in the United States and Europe, leading to as many as 1.6 million deaths3, and represents a substantial potential market opportunity for Allocetra™.
      • The study was designed for patients to be randomized with equal degree of SOFA scores across treatment and placebo groups.  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, as compared with the control group. Both of these patient attributes are associated with a significantly higher degree of difficulty of treatment and higher mortality rates. These imbalances made it challenging to deduce the relative effect in other patient subgroups.
    • Safety: Stand-alone and placebo-compared analysis across all sepsis patient subgroups and risk categories demonstrated acceptable safety and tolerability profile of Allocetra™ IV infusions.

Nes-Ziona, Israel, April 11, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company"))))), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive indication of effect and safety results from its Phase II study of Allocetra™ in patients with sepsis, in which 120 patients enrolled.

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 favorable 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."

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 favorable 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."

Posted In: ENLV