The 'Penicillin' of Antivirals, Xafty by Hyundai Bioscience, Opened a New Era of Treating Respiratory Viral Infections with Single Drug

- Professor Heungjeong Woo of Hallym University College of Medicine, announced the result of Xafty's clinical study at Emerging Science Session of the American Society for Microbiology (ASM) Microbe 2023

- Dr. Jo White evaluated Xafty's clinical results as "The birth of Penicillin of Antivirals" and "a groundbreaking achievement that suggests a solution to respiratory virus diseases"

HOUSTON, June 17, 2023 /PRNewswire/ -- The result of clinical study for EUA (emergency use authorization) on COVID-19 with Xafty (CP-COV03) was presented at the 'Emerging Science' session of the American Society for Microbiology (ASM) Microbe 2023 conference, one of the largest conferences on infections and microbiology held in Houston, Texas, on June 17, 2023. Dr. Heungjeong Woo, a professor from Hallym University School of Medicine, South Korea, presented the meaning and expected effects from the study, a randomized double-blinded placebo-controlled trial with 300 patients combining phase 2 and 3. Xafty is a novel antiviral oral drug developed by Hyundai Bioscience (KOSDAQ 048410) of South Korea.

This clinical study demonstrated the following great key results:

1. The blood concentration of the drug and the viral load showed a negative correlation.
2. The viral load decreased by 4.1% in the placebo group 16 hours after the first dose, whereas the Xafty group's viral load decreased by 56.65% (p-value 0.0185).
3. As a result, the time to improve twelve COVID-19 symptoms (fever, cough, sore throat, headache, etc.) was shortened by 4 days than that of the placebo group (p-value 0.0083).
4. Particularly, in the high-risk group where existing medication was allowed (hyperlipidemia, hypertension, diabetes medicine, etc.) was found that the time to improve twelve COVID-19 symptoms was shortened by 6 days compared to the placebo group (p-value 0.0080).

Niclosamide, the active pharmaceutical ingredient (API) of Xafty, has been found as effective against major viral infections (COVID-19, SARS, MERS, influenza, RSV, etc.) that cause respiratory infections by various in-vitro studies in the past decades. Since niclosamide is hard to be absorbed into the body, its effective blood concentration to inhibit viral replication cannot be maintained, making it difficult to be delivered to infected cells. With such problem not been solved, no significant progress was made in animal studies and clinical trials.