On December 3, 2020, the Company reported positive interim results of a Phase II investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe/critical condition.

The interim clinical results relate to eight COVID-19 patients who were treated with AllocetraTM in the Phase II clinical trial, six of whom were in severe condition and two of whom were in critical condition. Key results and conclusions from both the ongoing Phase II clinical trial, as well as a previously-reported investigator-initiated Phase Ib study include:

  • Seven out of seven (100%) patients treated through November 26, 2020 had complete recovery from their respective severe/critical condition and were discharged from the hospital, after an average of 4.7 days following AllocetraTM administration.
  • Taken together with previously-treated patients in the concluded Phase Ib study, twelve out of twelve patients (100%) through November 26, 2020 had complete recovery from their respective severe/critical condition and were discharged from the hospital, after an average of 5.5 days following AllocetraTM administration.
  • The eighth treated patient in the Phase II study (and 13th treated patient overall), who enrolled in the Phase II study in critical condition on November 27, 2020, has experienced a clinical improvement following treatment with AllocetraTM and was classified as moderate/severe condition on December 3, 2020. Clinical outcome will be included in the next interim results update.
  • AllocetraTM treatment has been well tolerated with no treatment-related serious adverse events.

Data from both the previously-reported investigator-initiated Phase Ib study and the ongoing investigator-initiated Phase II COVID-19 trials are shown below:

Clinical Trial # Patients enrolled Disease Severity Clinical Outcome Hospitalization
Post Administration of AllocetraTM
Recovered Mortality Discharged Duration
(days, avg.)
Phase Ib Patients
Phase Ib 3 Severe 3/3 (100%) 0/3 (0%) 3/3 (100%) 5
Phase Ib 2 Critical 2/2 (100%) 0/2 (0%) 2/2 (100%) 9
Total 5 5/5 (100%) 0/5 (0%) 5/5 (100%) 6.6
Phase II, Patients Enrolled Through November 26, 2020
Phase II 6 Severe 6/6 (100%) 0/6 (0%) 6/6 (100%) 4.5
Phase II 1 Critical 1/1 (100%) 0/1 (0%) 1/1 (100%) 6
Total 7 7/7 (100%) 0/1 (0%) 7/7 (100%) 4.7
Summary of Phase Ib + Phase II Patients Enrolled Through November 26, 2020
Total 12 12/12 (100%) 0/12 (0%) 12/12 (100%) 5.5
Phase II, Patients Enrolled After November 26, 2020
Phase II 1 Critical Patient enrolled Nov 27, 2020. Following treatment, clinical status
improved from Critical to Moderate/Severe on Dec 3, 2020. Clinical outcome will be included in the next interim results update.

AllocetraTM is being developed
to treat cytokine storms and multiple organ failure in sepsis patients and in COVID-19 patients

On October 13, 2020 Enlivex reported that the Israeli Ministry of Health authorized the initiation of a proposed investigator-initiated Phase II clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients. The planned COVID-19 study is a multi-center investigator-initiated, Phase II clinical trial. The trial is expected to recruit up to twenty-four COVID-19 patients in severe or critical condition, and is designed to assess AllocetraTM in combination with standard of care treatment. The trial plans to evaluate safety, tolerability, cytokine profile and efficacy parameters.