Telcon RF Pharmaceutical-KPM Tech, First Domestic Clinical Patient Dosed with Lenzilumab

[Asia Economy Reporter Hyungsoo Park] Telcon RF Pharmaceutical, an affiliate of KPM Tech, has officially started domestic clinical trials for a COVID-19 treatment.

Telcon RF Pharmaceutical announced on the 11th that the first patient dosing in the Phase 1 domestic clinical trial of Lenzilumab, conducted at Seoul National University Hospital, has begun.

The trial will evaluate the safety, tolerability, and pharmacokinetic properties of Lenzilumab in 20 Korean adults. The last patient dosing is scheduled to be completed in the second quarter. The clinical study report (CSR) is expected to be received within the fourth quarter of this year.

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.

Telcon RF Pharmaceutical and KPM Tech jointly hold the domestic rights to Lenzilumab, acquired from the U.S. company Humanigen.

A Telcon official stated, "The start of the clinical trial was delayed due to the spread of the Omicron variant of COVID-19," and added, "We plan to verify the safety of Lenzilumab in Koreans." He further explained, "If Humanigen obtains Emergency Use Authorization (EUA) in the U.S. or Conditional Marketing Authorization (CMA) in the U.K., we are preparing to apply for domestic import approval."

Lenzilumab is currently undergoing additional Phase 2/3 clinical trials under the ‘ACTIV-5 Big Effect Trial (ACTIV-5/BET-B),’ sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), at 55 sites in the U.S. and Korea.

This content was produced with the assistance of AI translation services.