Enlivex Therapeutics Ltd. (Nes Ziona, Israel), a clinical-stage immunotherapy company, has reported positive top-line results of an investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe/critical condition.

The clinical trial included five COVID-19 patients, three in severe condition and two in critical condition. All five patients had complete recovery from their respective severe/critical condition and were released from the hospital after an average of 5.5 days (severe) and 8.5 days (critical), following administration of Allocetra, at which time they were all COVID-19 PCR negative. There were no reported severe adverse events relating to the administration of Allocetra in the patients, and the therapy was well-tolerated.

Therapies such as plasma-based antibodies are typically administered to patients in moderate condition, whereas Allocetra was administered in the study to patients in severe or critical condition. The company believes that Allocetra, if approved, could potentially cover the gap that currently exists in treating severe or critical COVID-19 patients. Based on the positive results of the first five COVID-19 patients in severe or critical condition, taken together with the positive safety and efficacy results of Allocetra in 10 sepsis patients in a previous study, the company has determined to shift recruitment of additional patients from the investigator-initiated clinical trial into a larger Phase II clinical trial of COVID-19 patients in severe or critical condition as soon as reasonably practicable, subject to regulatory approval.

“We have now treated 15 patients with Allocetra at our hospital, 10 with sepsis, and five with COVID-19. Based on the compelling preliminary results that demonstrated safety and an indication of efficacy of Allocetra in these complicated patients, Enlivex’s product candidate has the potential to benefit COVID-19 patients in severe or critical condition,” said Prof. Vernon van Heerden, Head of the Critical Care Medicine Unit at Hadassah Hospital in Israel, and the lead investigator of both the COVID-19 trial and a recently-completed Phase Ib clinical trial of Allocetra in sepsis patients.

“We believe that the results of AllocetraTM treatment in these severe and critical COVID-19 patients represent a unique opportunity for Enlivex to contribute towards efforts aimed at combating the ongoing global COVID-19 pandemic. Importantly, the initial positive results seen in sepsis patients treated with AllocetraTM are consistent with those observed in COVID-19 patients in severe and critical condition,” said Prof. Dror Mevorach, M.D., Chief Scientific and Medical Officer of Enlivex.

“We are pleased with the results of this COVID-19 clinical trial. Enlivex will continue to work towards efforts aimed at combating the ongoing global COVID-19 pandemic, while continuing to execute our sepsis clinical development program. The cumulative clinical data to date from the clinical trials in sepsis and COVID-19 are in line with our expectations,” said Oren Hershkovitz, Ph.D., CEO of Enlivex.

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