Enlivex to launch Phase IIb Allocetra trial for COVID-19 patients in Israel

Seeking Alpha ^ | August 16 2021 | Mama Mayani

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Enlivex Therapeutics (NASDAQ:ENLV) reports that the Israeli Ministry of Health has authorized the initiation of its Phase IIb clinical trial evaluating Allocetra in severe and critical COVID-19 patients with acute respiratory distressed syndrome (ARDS).

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The Phase IIb trial is expected to recruit up to 152 COVID-19 patients and is designed to assess the safety and efficacy of Allocetra in addition to standard of care treatment. The trial will have two primary endpoints: ventilation-free survival and recovery for each of the two sub-populations of patients in the study (severe and critical). In addition, several secondary endpoints will be assessed, including evaluation of long-COVID-19 symptoms. Enlivex previously reported positive top-line results from Phase Ib and Phase II clinical trials of Allocetra in COVID-19. Aggregate data demonstrated that Allocetra was safe and well tolerated. Moreover, at the end of the 28-day follow-up period, a 0% mortality rate was observed and 90.5% of patients recovered and were discharged from the hospital after an average of 5.6 days. Read Next: Biophytis receives favorable DMC recommendation for late-stage Sarconeos study in COVID-19.