There were no reported severe adverse events relating to the administration of AllocetraTM in the patients, and the therapy was well-tolerated.

Therapies such as plasma-based antibodies are typically administered to patients in moderate condition, whereas AllocetraTM was administered in the study to patients in severe or critical condition.

The Company believes that, if approved, AllocetraTM 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 in addition to the positive safety and efficacy results of AllocetraTM 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 is reasonably practicable, subject to regulatory approval.

Comments from the Experts

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 AllocetraTM in sepsis patients, stated, “We have now treated 15 patients with AllocetraTM at our hospital, 10 with sepsis, and five with COVID-19. Based on the compelling preliminary results that demonstrated safety and an indication of the efficacy of AllocetraTM in these complicated patients, Enlivex’s product candidate has the potential to benefit COVID-19 patients in severe or critical condition.”

Prof. Dror Mevorach, M.D., Chief Scientific and Medical Officer of Enlivex, added, “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.” 

Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, “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.”

Any of the COVID-19 trials would be scheduled to run independently of Enlivex’s currently planned Phase IIb clinical trial of AllocetraTM for the treatment of organ failures associated with sepsis. The planned Phase IIb trial will be a controlled, randomized study that is expected to commence in the fourth quarter of 2020.

Enlivex Therapeutics

Enlivex is a clinical-stage immunotherapy company. The firm has developed an allogeneic drug pipeline for immune system rebalancing, which is critical for the treatment of life-threatening immune and inflammatory conditions which involve hyper-expression of cytokines (Cytokine Release Syndrome). This syndrome has no approved treatments (unmet medical needs) such as sepsis and COVID-19, as well as solid tumors immune-checkpoint rebalancing. 

Prohost Observations 

The successful results of AllocetraTM are real and cannot be ignored. Enlivex’s stock is now trading at $8.90 UP $2.96. More importantly is that the firm’s approach has saved 5 seriously and critically ill COVID-19 patients.  

We will continue to follow up on Enlivex’s larger future trials on COVID-19, as well as sepsis and Cytokine Release Syndrome. While looking at the firm’s past, we observed a resurrection that might reverse the stock’s direction from south to north.   

Enlivex Therapeutics Stock

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