Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the &ldquo, Company&rdquo, ))), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion to clinical sites in Spain of the Company's multi-center, placebo-controlled, randomized, dose-finding, Phase II trial of AllocetraTM in patients with pneumonia-associated sepsis.
The Phase II trial, which has multiple sites open for enrollment in Israel, is expected to include 120 to 160 patients across four cohorts receiving varying doses of AllocetraTM or placebo, all in addition to standard-of-care therapy. The trial's two primary endpoints are safety (number and severity of adverse events and severe adverse events) and efficacy (change from baseline in sequential organ failure (SOFA) score) assessments throughout a 28-day follow-up period. The trial is supported by previously reported positive results from a Phase Ib investigator-initiated trial, showing vastly improved clinical outcomes, including SOFA scores, duration of hospitalization, and mortality, in AllocetraTM-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, “Receiving authorization to expand our sepsis trial to Spain is an important first step in our broader plan to include several European countries as part of our ongoing clinical trials. We believe this also represents a notable regulatory achievement that provides additional validation for our study design and Allocetra’s manufacturing process, which was reviewed by the Spanish regulator as part of its review process. We would like to thank AEMPS for their review and look forward to the continued advancement of our sepsis program across both Europe and Israel.”
