Enlivex declares positive data from Phase II sepsis treatment trial

Enlivex Therapeutics has disclosed promising top-line results regarding safety and efficacy from its Phase II clinical trial evaluating Allocetra, an off-the-shelf cell therapy, for sepsis treatment.

This placebo-controlled, randomized trial aimed to determine the optimal dosage of Allocetra when administered alongside standard sepsis care for various infections like pneumonia, biliary, urinary tract, or peritoneal infections.

An independent analysis of subjects treated with Allocetra unveiled significant reductions in Sequential Organ Failure Assessment (SOFA) scores. Among these subjects, 78% were in septic shock, and 65% required invasive ventilation upon screening.

The study observed a notable 65% decrease in overall mortality rates compared to expected outcomes. Data further revealed a 90% decline in SOFA scores for urinary tract infection-related sepsis, 68% for community-acquired pneumonia, and 36% for internal abdominal infections by day 28.

Relative analyses suggest Allocetra's potential beneficial impact, particularly for severe sepsis patients, notably those at high risk from urinary tract infections.

Across various sepsis patient subgroups and risk categories, comparative analyses between Allocetra and placebo indicated an acceptable safety and tolerability profile for the therapy.