Humanised monoclonal antibody drug leronlimab has shown ‘impressive results’ in a small observational Covid-19 study, said the drug’s developer Cytodyn CEO Dr Nader Pourhassan in a conference call.
Originally developed to treat HIV, the drug is a CCR5 antagonist that inhibits viral entry. It is undergoing Phase II clinical trials as a treatment for HIV and secured fast-track designation from the US Food and Drug Administration (FDA).
The drug’s ability to mitigate cytokine storm is the basis for its study as a potential Covid-19 treatment.
The Covid-19 trial of the drug enrolled ten patients under emergency new drug authorisations at Montefiore Medical Center at the Albert Einstein College of Medicine, New York City, US.
According to initial data, leronlimab reduced the plasma viral load and restored the immune system of Covid-19 patients.
Diagnostic firm IncellDx CEO Dr Bruce Patterson also noted that the drug decreased plasma viral load and restored immune cells. IncellDX’s lab analysed blood samples of the first ten patients in the Covid-19 trial.
Patterson said: “That is remarkable for one drug to restore the immune system and decrease the viral burden in these patients. That is what gives us great hope and great excitement about leronlimab going forward in these trials.”
CytoDyn is recruiting participants for two Covid-19 trials. One is a Phase II randomised study for mild-to-moderate Covid-19 infection in the US.
The second is a Phase IIb/III randomised trial for severe and critically ill hospitalised Covid-19 patients across the country. Dosing in this trial began earlier this month.
Participants will receive leronlimab for two weeks. The primary endpoint is the mortality rate at 28 days, while a secondary endpoint is the mortality rate at 14 days.
Interim analysis will be performed on the trial results from 50 patients.