Enlivex Announces Completion of Enrollment of Its Phase II Trial Evaluating Allocetra In Patients With Sepsis

• Enrollment completed in placebo-controlled, randomized, dose-finding, multi-country, multi-center Phase II sepsis study
• Topline Data Expected in late Q1 2024

Nes-Ziona, Israel, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company completed enrollment of all 120 patients in its Phase II trial of Allocetra in patients with sepsis.

The Phase II trial is a placebo-controlled, randomized, dose-finding, multi-country, multi-center study, evaluating frozen-formulation Allocetra in addition to standard of care in patients with sepsis associated with pneumonia, biliary, urinary tract, or peritoneal infections. Sepsis is a life-threatening disease with no therapies approved by the U.S. Food and Drug Administration and a high unmet need. Each year, more than 1.7 million adults in the United States develop sepsis, with annual mortality of more than 270,000 due to the disease.

“The completion of the enrollment in our Phase II trial of Allocetra in patients with sepsis is an important execution milestone for Enlivex, meeting our enrollment timeline” stated Einat Galamidi, Medical Vice President of Enlivex. “We expect, in line with our prior timeline guidance, to report the top-line data readout from the trial by the end of Q1 2024. We appreciate the hard work of the investigators involved in this trial across multiple medical centers, and the patients who have helped us achieve this key milestone.”

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.