Telcon RF Pharmaceutical "Approval of Domestic Clinical Trial Plan for COVID-19 Treatment"

[Asia Economy Reporter Hyunseok Yoo] Telcon RF Pharmaceutical and KPM Tech have secured the domestic clinical trial plan approval for the COVID-19 treatment they hold the rights to.

Telcon RF Pharmaceutical and KPM Tech announced on the 22nd that the Ministry of Food and Drug Safety (MFDS) approved the domestic Phase 1 clinical trial plan for Lenzilumab. This clinical trial will be conducted at Seoul National University Hospital, evaluating the safety, tolerability, and pharmacokinetic properties of Lenzilumab in 20 Korean adult subjects.

A representative from Telcon RF Pharmaceutical stated, “If safety is verified through this domestic clinical trial, it will be possible to apply for domestic import approval based on the results of the Phase 3 clinical trial in the United States without additional clinical trials,” adding, “If Lenzilumab obtains Emergency Use Authorization (EUA) in the U.S., we plan to immediately apply for domestic import approval.”

Lenzilumab is a new drug candidate that treats the immune overreaction caused by the cytokine storm, a major cause of death in COVID-19 patients. Humanigen, the developer of Lenzilumab, completed Phase 3 clinical trials in the United States and Brazil and applied for EUA with the U.S. Food and Drug Administration (FDA) in May.

Lenzilumab demonstrated excellent efficacy in the Phase 3 clinical trials conducted in the U.S. and Brazil. Compared to patient groups treated with the previously approved COVID-19 treatments Remdesivir and corticosteroids, the survival without ventilation (SWOV) rate was 92% higher, and compared to the placebo group, it improved by 54%.

Telcon RF Pharmaceutical and KPM Tech secured the domestic and Philippine regional rights for Lenzilumab from Humanigen in November last year.

A representative from Telcon RF Pharmaceutical said, “As social distancing has been raised to level 4 and the number of new COVID-19 cases in Korea continues to exceed 1,000 daily, we are preparing to ensure that Lenzilumab can be rapidly introduced domestically in the future.”