- The Israeli Ministry of Health has signed off Enlivex Therapeutics Ltd's ENLV Phase 2b trial evaluating Allocetra in severe and critical COVID-19 patients with the acute respiratory distressed syndrome (ARDS).
- The Phase 2b trial will recruit up to 152 severe or critical COVID-19 patients in clinical centers in Israel and certain European countries.
- The trial is designed to assess the safety and efficacy of Allocetra when administered in addition to standard of care treatment.
- The planned Phase 2b trial will have two primary endpoints: ventilation-free survival and recovery.
- In addition, the trial will assess several secondary endpoints, including evaluation of long-COVID-19 symptoms.
- Enlivex previously reported positive top-line results from Phase 1b and Phase 2 investigator-initiated trials.
- Aggregate data from the two trials demonstrated that Allocetra was safe and well-tolerated.
- At the end of the 28-day follow-up period, a 0% (0/21) mortality rate was observed.
- 90.5% (19/21) of patients recovered from their respective severe/critical condition and were discharged from the hospital after an average of 5.6 days following Allocetra administration.
- Price Action: ENLV shares are up 21.80% at $12.39 during the premarket session on the last check Monday.
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