Enlivex Therapeutics has reported positive topline safety and efficacy data from its Phase II clinical trial of Allocetra, an off-the-shelf cell therapy, in treating sepsis.

The placebo-controlled and randomised trial is designed to determine the optimal dose of Allocetra when used alongside the standard of care for sepsis resulting from various infections.

The study focused on patients with sepsis associated with pneumonia, biliary, urinary tract, or peritoneal infections.

A stand-alone analysis of subjects treated with Allocetra revealed that patients experienced significant reductions in Sequential Organ Failure Assessment (SOFA) scores.  

Of the Allocetra-treated subjects, 78% were in septic shock and 65% required invasive ventilation at the time of screening.

A 65% decrease in the overall mortality rate compared to expected outcomes was observed.

Data indicated a 90% decline in SOFA scores for sepsis patients with urinary tract infections, 68% for those with community-acquired pneumonia, and 36% for internal abdominal infections by day 28.

Relative analysis suggests that Allocetra may have a beneficial impact on patients with severe sepsis, particularly those at high risk from urinary tract infections.

Throughout the different sepsis patient subgroups and risk categories, the analyses comparing Allocetra to the placebo demonstrated that the therapy has an acceptable safety and tolerability profile.

Enlivex Therapeutics CEO Oren Hershkovitz 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, randomised, controlled study of a solely high-risk UTI sepsis population.”

In February 2023, the company received authorisation from the Spanish Agency of Medicines and Medical Devices (AEMPS) for the expansion of its Phase I/II clinical trial of Allocetra in subjects with advanced solid malignancies.