Business
Enlivex Receives Regulatory Authorization to Expand its Phase IIb Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients into Greece
Nes-Ziona, Israel, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming
About this update from Enlivex Ltd.
[{"type":"text","content":"Nes-Ziona, Israel, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that, following a review of the Company’s preclinical and clinical data, study design, and manufacturing process, Greece’s National Organization of Medicines 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 the country. The placebo-controlled trial, which is currently enrolling patients at clinical trial sites in Israel and was recently cleared to expand into Spain, 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), and could potentially be sufficient for obtaining emergency or conditional marketing authorization for either patient sub-population, though no guidance as to the potential for such emergency or conditional marketing authorization has been provided by the Israeli Ministry of Health or European regulators. Enlivex currently expects that top-line data from the trial will be available in late 2022 or Q1 of 2023. The ongoing Phase IIb 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, “This latest authorization to expand the geographic reach of one of our clinical trials provides yet another example of our team’s ability to successfully execute on our regulatory strategy. Looking ahead, we expect the strength of our data and the rigor...