South Korea’s Ministry of Food and Drug Safety (MFDS) has granted approval to Humanigen’s partners, Telcon RF Pharmaceutical and KPM Tech, to carry out Phase I clinical trial of lenzilumab in hospitalised Covid-19 patients.
Telcon and KPM are Humanigen’s development and marketing partners for South Korea and the Philippines regions.
An antibody that attaches to and deactivates granulocyte-macrophage colony-stimulating factor (GM-CSF), lenzilumab is being developed to treat cytokine storm.
The randomised, placebo-controlled, double-blind, single-dose, dose-escalation Phase I trial will enrol a total of 20 healthy adult subjects in Korea.
Telcon and KPM are responsible to conduct the trial at the Seoul National University Hospital.
The safety, tolerability and pharmacokinetics of the antibody will be the trial’s primary goals.
The company noted that if the US Food and Drug Administration (FDA) grants emergency use authorization (EUA) to lenzilumab for Covid-19, Telcon and KPM Tech will seek conditional approval for the antibody in Korea.
Supporting data for conditional approval to import the drug will be based on results from the latest Phase I trial and those from its Phase III LIVE-AIR trial, Humanigen said.
LIVE-AIR data showed that the use of lenzilumab at an early stage of Covid-19 infection could avert consequences caused by a cytokine storm in hospitalised patients.
Humanigen CEO Dr Cameron Durrant said: “We believe the data for lenzilumab from our Phase III LIVE-AIR study demonstrates the meaningful improvement in patient care that is possible with the use of lenzilumab to treat patients hospitalised with Covid-19 pneumonia.
“We are hopeful that these data, alongside data generated in Korea by our partners, will allow for the use of lenzilumab in South Korea.”
Last month, Humanigen commenced a rolling review submission to the UK Medicines and Healthcare Products Regulatory Agency (MHRA), seeking marketing approval for lenzilumab.
Apart from lenzilumab, the company is developing a portfolio of clinical and pre-clinical treatments for inflammation and immuno-oncology indications.