Enlivex Therapeutics Ltd. (NASDAQ:ENLV) shares rose sharply Monday after the company disclosed that after reviewing its earlier-reported Phase II trial data, the Israeli Ministry of Health has authorized the initiation of a multi-center, placebo-controlled, randomized, blinded, Phase IIb clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients with acute respiratory distressed syndrome.
The Phase IIb trial is expected to recruit up to 152 severe or critical COVID-19 patients in clinical centers in Israel and certain European countries, and is designed to assess the safety and efficacy of Allocetra TM when administered in addition to standard of care treatment.
Enlivex previously reported positive top-line results from Phase Ib and Phase II investigator-initiated clinical trials of Allocetra TM in COVID-19 patients in severe and critical condition. Aggregate data from the two trials demonstrated that Allocetra TM was safe and well tolerated. Moreover, at the end of the 28-day follow-up period, a 0% (0/21) mortality rate was observed and 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 TM administration.
CEO Oren Hershkovitz, and Prof. Dror Mevorach, Chief Scientific Officer of Enlivex, stated in a joint comment: “We would like to thank the Israeli Ministry of Health for the expedited review and for authorizing a Phase IIb clinical trial of Allocetra in COVID-19 patients in severe and critical condition
ENLV shares hiked /$2.26, or 22.2%,to $12.43.