Benzinga | Sep 22, 2021 06:08AM EDT

Enlivex Dosed First Patient in Placebo-Controlled Phase IIb Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients with ARDS

Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company")), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, today announced the initiation of dosing in its multi-center, placebo-controlled, randomized, blinded, Phase IIb clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients with acute respiratory distress syndrome (ARDS).

The Phase IIb trial is expected to recruit up to 152 severe or critical COVID-19 patients (76 AllocetraTM plus standard-of-care, 76 placebo plus standard-of-care) in clinical centers in Israel and certain European countries, and is designed to assess the safety and efficacy of AllocetraTM when administered in addition to standard-of-care treatment. The co-primary endpoints of the trial are ventilation-free survival and recovery for each of its two patient sub-populations (severe and critical). In addition, the trial will assess several secondary endpoints, including evaluation of long-COVID-19 symptoms. Top-line data from the trial are expected in the second quarter of 2022.

"We believe that recent variant-driven surges in COVID-19 cases around the world have emphasized the need for novel treatments that can address the most serious forms of the disease," said Dr. Oren Hershkovitz, Chief Executive Officer of Enlivex. "They also reinforce our belief that even with vaccines available, COVID-19 will migrate from a pandemic to an endemic, with multiple variants continuing to circulate throughout the population. Through Allocetra's continued development, we hope to provide physicians with an effective treatment option that can improve survival and decrease the length of hospitalization for patients in severe or critical condition. The initiation of dosing in our Phase IIb trial represents an important step towards this goal. The study was already approved by several Ethics Committees from leading Israeli hospitals, and we are committed to accelerate the patient's recruitment by opening many sites both in Israel and specific EU countries as fast as possible".

Prof. Dror Mevorach, Chief Scientific Officer of Enlivex, added, "We believe AllocetraTM has a broadly applicable mechanism of action for reprogramming macrophages and that was demonstrated through the promising results in prior clinical trials in severe and critical COVID-19 patients. We aim to build on these data through the progression of this placebo-controlled Phase IIb study and look forward to its continued advancement."

Enlivex previously reported positive top-line results from Phase Ib and Phase II investigator-initiated clinical trials of AllocetraTM in COVID-19 patients in severe and critical condition. Aggregate data from the two trials demonstrated that AllocetraTM was safe and well tolerated. Moreover, at the end of these trials' 28-day follow-up periods, 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 AllocetraTM administration.