TelconRF Pharmaceutical Receives IRB Approval for Domestic Clinical Trial of COVID-19 Treatment 'Lenzilumab'

[Asia Economy Reporter Hyungsoo Park] Telcon RF Pharmaceutical announced on the 8th that it will officially begin domestic clinical trials of the COVID-19 treatment 'Lenzilumab' in collaboration with KPM Tech.

Telcon RF Pharmaceutical explained that after receiving clinical trial plan approval from the Ministry of Food and Drug Safety in July, it obtained Institutional Review Board (IRB) approval for domestic clinical trials of Lenzilumab from Seoul National University Hospital on the 6th. The hospital will evaluate the safety, tolerability, and pharmacokinetic properties of Lenzilumab in 20 Korean adult subjects.

Lenzilumab is a monoclonal antibody drug candidate that treats immune overreaction caused by cytokine storm, a major cause of death in COVID-19 patients. Humanigen, the developer of Lenzilumab, completed successful Phase 3 'LIVE-AIR' clinical trials in the United States and Brazil and applied for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on May 28.

Lenzilumab demonstrated excellent efficacy in the global LIVE-AIR Phase 3 clinical trial. Compared to patient groups treated with the already approved COVID-19 treatments remdesivir and corticosteroids, the relative survival without ventilation (SWOV) was 92% higher. It improved by 54% compared to the placebo group. In patients under 85 years old with C-reactive protein (CRP) levels below 150 mg/L, the relative SWOV was improved threefold compared to those treated with remdesivir and corticosteroids.

Telcon RF Pharmaceutical and KPM Tech secured domestic and Philippine regional rights for Lenzilumab from Humanigen in November last year and are currently advancing domestic clinical trials. Upon passing domestic trials, they can apply for domestic import product approval based on the U.S. Phase 3 clinical trial results. Telcon RF Pharmaceutical and KPM Tech plan to apply for domestic import product approval as soon as Lenzilumab obtains U.S. Emergency Use Authorization (EUA).

A Telcon RF Pharmaceutical official stated, "Since IRB approval has been obtained, clinical trials such as patient enrollment are expected to begin in earnest."