Enlivex receives authorizations from French, Belgian to expand Sepsis trial

Enlivex Therapeutics announced that the French Agency for Food, Environmental and Occupational Health and Safety, ANSES, and the Belgian Federal Agency for Medicines and Health Products, FAMHP, have cleared the amended protocol of the Company’s Phase II trial evaluating Allocetra in patients with sepsis. The approved protocol, which previously received clearances in Israel, Greece and Spain, enables the treatment of newly recruited patients with a frozen Allocetra formulation, as well as an expansion of the study’s target population, which was originally limited to patients with pneumonia-associated sepsis, to include patients whose septic condition stems from biliary, urinary tract or abdominal infections. The Phase II trial is expected to include 80 to 160 patients across four cohorts, receiving varying doses of either Allocetra or a placebo, all in addition to standard-of-care therapy. The trial’s two primary endpoints are safety and efficacy assessments throughout a 28-day follow-up period. The trial is supported by previously reported positive results from a Phase Ib investigator-initiated trial that showed vastly improved clinical outcomes, including SOFA scores, duration of hospitalization, and mortality, in Allocetra-treated sepsis patients, as compared to a group of matched historical controls who received standard-of-care therapy. Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, "Expanding the study to France and Belgium with frozen formulation AllocetraTM is an important step in the execution of our ongoing Phase II sepsis trial. We also believe that this is a notable regulatory achievement that provides additional validation for our amended study design and AllocetraTM frozen formulation."