Telcon RF Pharmaceutical's corporate logo (Telcon RF)
Telcon RF Pharmaceutical has received approval to carry out a phase 1 clinical study of Humanigen‘s COVID-19 treatment lenzilumab in South Korea, the company said Thursday.
Lenzilumab is a monoclonal antibody drug developed by Humanigen for treating hospitalized patients with COVID-19.
Telcon RF and its parent company KPM Tech are responsible for gaining regulatory approval and commercialization authorization of lenzilumab in South Korea and the Philippines, under the licensing transaction made in November last year.
Telcon RF, together with KPM Tech, will conduct the phase 1 clinical study at Seoul National University Hospital with some 20 adult participants, according to the company.
Telcon RF added that it plans to seek approval to import the monoclonal antibody drug if the US Food and Drug Administration grants emergency use authorization for lenzilumab.
If Humanigen obtains emergency use authorization based on the company’s phase 3 clinical trial of lenzilumab, Telcon RF and KPM Tech could skip additional clinical studies in South Korea, which will speed up introduction of the COVID-19 treatment in the country, an official from Telcon RF said.
In May, Humanigen submitted an application to the US FDA, requesting emergency use authorization for lenzilumab based on its phase 3 clinical study.
According to the clinical data, COVID-19 patients who received lenzilumab showed a 54 percent relative improvement in the chances of survival without ventilation versus the placebo group.
The study also showed a 92 percent relative improvement in survival without ventilation among patients who received both corticosteroids and remdesivir.
By Shim Woo-hyun (firstname.lastname@example.org