Benzinga | Nov 10, 2021 08:13AM EST

Spanish Regulator Grants Enlivex Authorization To Expand Its Phase IIb Trial Evaluating Allocetra In Severe And Critical COVID-19 Patients Into Spain

Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the &quot, Company&quot, ))))), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion of the Company's Phase IIb trial evaluating AllocetraTM in severe and critical COVID-19 patients with acute respiratory distress syndrome (ARDS) to sites in Spain.



The placebo-controlled trial, which is currently enrolling patients at clinical trial sites in Israel, is expected to recruit up to 152 severe or critical COVID-19 patients. It is designed to assess the safety and efficacy of AllocetraTM when administered in addition to standard of care treatment. The trial's two primary endpoints are ventilation-free survival and recovery for each of the two sub-populations of patients in the study (severe and critical). The trial is supported by previously reported positive 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 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 AllocetraTM administration.



Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, "We are very pleased to have regulatory clearance to expand our COVID-19 trial to Spain. We believe AEMPS' decision to authorize this expansion, together with their prior decision authorizing the expansion of our sepsis trial, speaks to Allocetra's broadly applicable mechanism of action, the strength of our clinical datasets, and the rigor of our study designs and manufacturing process. The inclusion of several European countries in our ongoing clinical trials is an important component of our regulatory strategy, and one that we plan to continue executing by working with regulatory agencies in additional countries."