Enlivex Therapeutics is to begin a Phase IIb clinical trial of universal, off-the-shelf cell therapy, Allocetra, in severe and critical Covid-19 patients with acute respiratory distressed syndrome (ARDS).
Certain diseases, including solid cancers, sepsis and Covid-19 among others, reprogramme macrophages out of their homeostatic state and cause disease severity.
Allocetra can potentially reprogramme macrophages into their homeostatic state to offer a new immunotherapeutic mechanism of action for life-threatening diseases with unmet medical needs, Enlivex noted.
The Israeli Ministry of Health reviewed Phase II trial data of the therapy and authorised the commencement of its Phase IIb trial.
The company-sponsored, multi-centre, placebo-controlled, randomised and blinded Phase IIb trial will evaluate the safety and efficacy of Allocetra when given with the standard of care therapy.
It will enrol a total of up to 152 subjects at clinical sites in Israel and selected European countries.
The primary goals of the trial are ventilation-free survival and recovery for each of the severe, as well as critical subject sub-populations in the trial.
Furthermore, analysis of long-Covid-19 symptoms will be one of the secondary goals of the trial.
Enlivex had reported positive top-line data from Phase Ib and Phase II investigator-initiated trials of Allocetra in patients with severe and critical Covid-19.
Combined results from the trials showed that the cell therapy was safe and well-tolerated.
No deaths were reported in subjects receiving Allocetra by day 28 of the follow-up period.
In addition, 90.5% of severe/critical subjects had improvement in their condition and were discharged from the hospital after an average of 5.6 days.
Enlivex CEO Oren Hershkovitz and chief scientific officer professor Dror Mevorach said in a joint statement: “We would like to thank the Israeli Ministry of Health for the expedited review and for authorising a Phase IIb clinical trial of Allocetra in Covid-19 patients in severe and critical condition.”
In another development, the US Food and Drug Administration has approved Novatek Pharmaceuticals’ investigational new drug (IND) application to conduct a Phase II trial of its oral drug, TQ Formula, for Covid-19 in the outpatient setting.
TQ Formula is a concentrated enteric-coated Nigella Sativa oil formulation with a high thymoquinone concentration.
Cell & Gene Therapy Coverage on Clinical Trials Arena supported by Cytiva.
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