Enlivex Topline Results of Phase II Septic Shock Trial Mixed

 

• Analysis of eligible1 patients from the sepsis Phase II study (NCT# NCT04612413)
• 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.

https://www.globenewswire.com/news-release/2024/04/11/2861472/0/en/Enlivex-Announces-Topline-Results-of-Its-Phase-II-Trial-Evaluating-Allocetra-In-Patients-With-Sepsis.html