Humanigen Inc. announced its development and commercialization partners for South Korea and the Philippines, Telcon RF Pharmaceutical Inc. and KPM Tech Co., Ltd. have received approval from South Korea's MFDS (the South Korean equivalent of the U.S. FDA) to conduct a Phase 1 clinical study of lenzilumab, which may support potential use in the treatment of hospitalized COVID-19 patients. The study, to be conducted by Telcon and KPM Tech at the Seoul National University Hospital, is a randomized, placebo-controlled, double-blind, single-dose, dose escalation of lenzilumab in 20 healthy Korean adults. The primary endpoints of the study are the safety, tolerability, and pharmacokinetics of lenzilumab.

If FDA grants emergency use authorization for lenzilumab in the treatment of hospitalized COVID-19 patients in the United States, Telcon and KPM Tech plan to apply to MFDS for conditional approval for importation of lenzilumab for use in Korea. Support for conditional approval would be based on data from this phase 1 study and the existing data from Humanigen's Phase 3 LIVE-AIR study. Additional clinical trials are not expected to be necessary in this situation.