Clinical-stage immunotherapy company Enlivex Therapeutics has reported positive interim data from the Phase II clinical trial of Allocetra in severe and critical Covid-19 patients.
The multi-centre, investigator-initiated trial is evaluating Allocetra’s safety, tolerability, cytokine profile and efficacy parameters in combination with standard of care treatment.
It will enrol about 24 patients with severe or critical Covid-19, as defined by the US National Institute of Health (NIH).
The interim analysis was conducted on six patients with severe disease and two in critical condition.
According to data from the ongoing Phase II trial and previously reported investigator-initiated Phase Ib study, all (seven) patients treated until 26 November had a complete recovery from their severe/critical condition.
They were discharged from the hospital after an average of 4.7 days following the treatment.
Together with previously treated patients from Phase Ib study, all (12) patients who received Allocetra had a complete recovery and were discharged from the hospital after an average of 5.5 days.
In the Phase II study, an eighth critically ill patient enrolled on 27 November showed clinical improvement on receiving the treatment and is hospitalised with moderate/severe condition.
Data from the Phase Ib study showed that an average of nine days to hospital discharge was observed following the treatment in critical patients.
Allocetra was well tolerated with no treatment-related serious adverse events.
Enlivex chief scientific and medical officer Prof Dror Mevorach said: “We believe the results from the Covid-19 clinical trials of Allocetra represent a unique opportunity for Enlivex in this Covid-19 patient population, and suggest that Allocetra may have utility as a safe and efficacious treatment for resolving states of organ failures across different life-threatening, high mortality clinical indications with high unmet medical needs.”