Enlivex Announces Peer-Reviewed Publication in Frontiers in Immunology of Clinical Data Details Resolution of Acute Respiratory Distress Syndrome (ARDS) from two Phase I/II Trials Evaluating Allocetra in Patients with COVID-19

Data published in Frontiers in Immunology show a robust safety profile and rapid resolution from ARDS and parallel resolution of inflammation markers and elevated cytokines/chemokines, as well as substantial improvements in mortality in 21 Allocetra-treated patients with COVID-19 vs. matched historical controls

Nes-Ziona, Israel, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the peer-reviewed publication of clinical and exploratory data from a Phase Ib and a Phase IIa clinical trial in Frontiers in Immunology. The paper, entitled “Apoptotic cells for treatment of acute respiratory distress syndrome (ARDS) associated with COVID-19” describes a multicenter study that was published in collaboration with researchers at Hadassah-Hebrew University Medical Center, Barzilai Medical Center and Ziv Medical Center Israel.

Data presented in the paper was derived from 21 severe and critical COVID-19 patients treated with a single dose of Allocetra^TM in addition to standard of care during the peak of the COVID-19 pandemic. 19 out of the 21 treated patients had mild-to-severe ARDS with their COVID-19. The Phase I/II clinical trials evaluated the safety profile of Allocetra treatment as well as recovery from ARDS, intensive care unit (ICU) and hospital length-of-stay inflammatory parameters and cytokine/chemokine profile. The mortality rate was compared to a matched control group hospitalized during the same period at Hadassah Medical Center.

“This study had excellent results, leading to early discharge from a hospital of 17 out of 19 patients with ARDS along with resolution of the cytokine storms observed in these patients. We believe that the current peer-reviewed publication provides an additional important external validation for Allocetra^TM and its broadly applicable mechanism of action in treating ARDS that manifested due to viral infection complications such as severe and critical COVID-19,” said Prof. Dror Mevorach, M.D., Chief Scientific Officer of Enlivex and lead author of the publication.

“ARDS is a difficult disease indication with poor treatment options for patients. The global ARDS market size is estimated at approximately $1 billion, and is expected to reach more than $2 billion by 2030,” stated Oren Hershkovitz, CEO of Enlivex. “We believe Allocetra^TM could potentially become a leading therapy for ARDS patients, and while Enlivex’s clinical development slate is currently full with multiple clinical trials ongoing and planned for 2024, we will be seeking out-licensing or partnering opportunities to potentially continue via a third party the clinical development of Allocetra^TM for ARDS.”