Enlivex Therapeutics has received authorisation from the Spanish Agency of Medicines and Medical Devices (AEMPS) to expand its Phase IIb clinical trial of cell therapy Allocetra in Covid-19 patients to sites in the country.
The multi-centre, placebo-controlled, blinded, randomised clinical trial will assess the universal, off-the-shelf therapy to treat severe and critical patients with Covid-19 who have acute respiratory distress syndrome (ARDS).
Many diseases such as sepsis, Covid-19 and solid cancers reprogramme macrophages out of their homeostatic state and significantly contribute to the disease severity.
Allocetra is being developed to restore macrophage homeostasis and offer a new immunotherapeutic mechanism of action for life-threatening diseases that are defined as ‘unmet medical needs’.
It can be used as a standalone treatment or along with other therapeutic agents.
In this Phase IIb trial, the efficacy and safety of the cell therapy will be investigated when given in addition to standard of care therapy.
It is currently enrolling subjects at clinical sites in Israel and is anticipated to recruit up to 152 patients.
Survival without ventilation and recovery for each of the severe and critical subject sub-populations are the two primary goals of the trial.
Enlivex CEO Oren Hershkovitz said: “We believe AEMPS’ decision to authorise this expansion, together with their prior decision authorising the expansion of our sepsis trial, speaks to Allocetra’s broadly applicable mechanism of action, the strength of our clinical datasets, and the rigour 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.”
The company stated that the Phase IIb trial is supported by the previously reported positive data obtained from Phase Ib and Phase II investigator-initiated trials of the therapy in severe and critical Covid-19 patients.
The total data from the trials showed that the off-the-shelf cell therapy was safe and well-tolerated, and no deaths were reported on day 28 of the follow-up period.
Additionally, 90.5% of subjects recovered from their condition and were discharged from the hospital after an average of 5.6 days after taking Allocetra.