Enlivex Therapeutics Ltd. 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 AllocetraTM 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.

Key data and conclusions from the paper include: Allocetra-treated patients (17/19) exhibited rapid resolution from their ARDS. Allocetra-treated patients (N=21) had a mortality rate of 0% with complete recovery of 19/21 patients at the end of the study's 28-day follow-up period, compared to a mortality rate of 3.8%-8.9% for age- and gender-severe COVID-19-matched patients, and 39%-55% for critical patients. Average duration of hospitalization post-administration of AllocetraTM for discharged patients was 5.6 days All patients had elevated pro- and anti-inflammatory cytokines, chemokines, and additional immune modulators that steadily decreased following AllocetraTM treatment.

No serious related adverse events were reported with AllocetraTM treatment with an overall favorable safety profile.