Enlivex Therapeutics announces results of its Phase II trial of Allocetra

Enlivex Therapeutics announced positive indication of effect and safety results from its Phase II study of Allocetra in patients with sepsis, in which 120 patients enrolled. Analysis of eligible1 patients from the sepsis Phase II study: In accordance with the study protocol, the safety and efficacy topline analysis includes sequential organ failure assessment 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 mortality. 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, originating from urinary tract infections. 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 Allocetr. 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(TM)-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.