Enlivex Therapeutics Announces Positive Interim Safety and Efficacy Data From Ongoing Trial of Off-The-Shelf Allocetra in Patients with Severe Sepsis

— Interim Analysis Comparing Allocetra-Treated Patients with 37 Severe Sepsis Patients with Equivalent Source of Infection and Disease Severity Who Were Hospitalized at the Same Hospital, Demonstrates Potential of Allocetra as Therapy for Prevention of Sepsis-Associated Organ Failure and Mortality — Nes Ziona, Israel, Nov. 04, 2019 — Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunotherapy company, today announced positive interim efficacy data from the Company’s ongoing Phase Ib clinical trial in patients with severe sepsis. The interim analysis is based on a dataset of 43 patients with severe sepsis, all hospitalized at Hadassah Medical Center, which is one of the largest and most prestigious hospitals in Israel. Six patients admitted to Hadassah’s intensive care unit with sepsis have been administered with off-the-shelf Allocetra (“OTS Allocetra”) upon their admission, while 37 patients were matched controls that received standard of care treatment during 2016-2019 but did not receive OTS Allocetra. The primary safety parameter was 28 days mortality. None (0 of 6) of the OTS Allocetra -treated patients died during this period, compared to 11 of 37 (29%) in the matched control group who died during this period. OTS Allocetra treatment resulted in improved efficacy in all analyzed parameters, which included the sequential organ failure assessment (SOFA) score (the higher the score, the worse the clinical condition of various organs), as well as recovery from sepsis, number of days of hospitalization in the intensive care unit, and others. The interim and efficacy data are as follows: Sepsis Outcomes Matched Untreated Group OTS Allocetra Treated Group % of patients that recovered from sepsis within 28 days Significant increase in recovery from sepsis in patients that were treated with Allocetra-OTS 48 % 100 % % mortality of patients 29 % 0 % Average organ failure score (SOFA) at admission vs maximal reached during hospitalization OTS Allocetra substantially prevents organ failure in severe sepsis patients Avg. at admission: 3.98 Avg. maximal: 8.11 Avg. at admission: 4.5 Avg. maximal: 4.5 Median organ failure score (SOFA) at admission vs maximal reached during hospitalization Median at admission: 4 Median maximal: 8 Median at admission: 4.5 Median maximal: 4.5 % of patients with organ failure score (SOFA) that increased during 28-day period SOFA increase is associated with organ dysfunction and failure, and was prevented in patients treated with OTS Allocetra 78 % 0 % % of patients with organ failure score (SOFA) that increased by 4 or more points during 28 days SOFA increase => 4 is associated with high probability of mortality, and was prevented in patients treated with OTS Allocetra 57 % 0 % % of patient mortality among those with organ failure score (SOFA) that increased by 4 or more during 28 days 52 % 0 % % of patients still in the intensive care unit after 6 days 57 % 0 % Prof. Dror Mevorach, Chief Medical Officer of Enlivex, commented, “We are pleased with the robust safety and efficacy profile demonstrated by OTS Allocetra in the interim analysis of patients with severe sepsis. Even in a small group of patients, some of the efficacy parameters are already statistically-significant. Our previous analysis showed that no serious adverse events were associated with OTS Allocetra in these patients. Together with our preclinical data, as well as human data from a Phase IIa clinical trial relating to the prevention of GvHD, we believe that OTS Allocetra is positioned as a potentially clinically viable option for treatment of sepsis, which is a clinical condition that has poor clinical outcomes and no currently effective therapy.” Shai Novik, Chairman of Enlivex, stated, “We are encouraged by these interim safety and efficacy analysis results. OTS Allocetra is a significant product candidate for Enlivex, and we look forward to obtaining additional clinical data. We hope to complete the ongoing study by the end of 2019 and provide a final efficacy data analysis shortly thereafter.” The matching of the 37 patients to the OTS Allocetra-treated group was based on similar organ failure clinical SOFA score at admission, overall clinical state, age group, sex, and source of severe sepsis (pneumonia, endovascular, or urinal tract infections). All matched patients were treated at the same hospital as the Allocetra-treated group.

The release as fetched from its publisher. enlivex.com ↗