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 18, 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.

Hyundai Bioscience overcame the challenge of niclosamide with its proprietary drug delivery technology using bio-compatible inorganic compound and polymer so that niclosamide is properly absorbed into the body and stays in the intestine for a prolonged time for slow release, enabling the effective antiviral concentration of niclosamide to be maintained for 5 days. The main target of the respiratory virus is the lung, where numerous blood vessels for oxygen supply exist. It was confirmed that Xafty delivers niclosamide well to the lung through the blood while maintaining an effective antiviral concentration. Hyundai Bioscience's animal testing demonstrated the concentration of niclosamide delivered to the lung was 2 to 10 times higher than in the blood.

Professor Woo said that the clinical result of Xafty has three meanings.

First, it made it possible to treat human viral infections by overcoming the problems (low absorption rate and short half-life) of niclosamide, which had been found to be effective in various viruses by in-vitro studies.

Second, it was confirmed that, if niclosamide is found to be effective against the respiratory virus by in-vitro or animal tests, treating the viral infection in humans can also be achieved.

Third, the viruses that has caused the pandemic so far are all respiratory and RNA viruses that cause endless mutations. Due to the nature of RNA viruses, it is impossible to develop a treatment for each individual virus.

Xafty presented an innovative way to treat multiple respiratory viral infections with a single drug.

More than half of viral infections are respiratory infections, and six families of viruses (Coronaviruses such as COVID-19, Orthomyxoviridae such as influenza, Paramyxoviridae, Picornaviridae, Adenoviridae, and Herpesviridae) are known to cause respiratory infections. Currently, there is no cure for respiratory viral infections other than COVID-19 and influenza and no drugs are discovered.

In-vitro studies from 2004 to 2021 have discovered that niclosamide, the main pharmaceutical ingredient of Xafty, is effective against not only the six families of respiratory viruses, but also against the eight families of viruses (Coronavirus including COVID-19, SARS and MERS, Orthomyxovirus, Paramyxovirus, Picorna virus, Flavivirus, Buniya virus, Filovirus, and Alphavirus) that NIH and Bill & Melinda Gates Foundation decided to support the development of treatments for future pandemics.(U.S. Biden administration has decided to support $88.2 billion for 5 years to prepare for future pandemics.)

Dr. Jo White, a viral disease expert with 35 years of experience in clinical research at pharmaceutical companies such as Merck and BMS, commented on the result of Xafty's clinical study, "With the advent of penicillin antibiotics, mankind had been freed from fear of bacterial pandemic. As such, the birth of Xafty, the 'penicillin' of antivirals, may be viewed as a groundbreaking achievement that presents a solution to respiratory viral infections in the future."

[About Hyundai Bioscience]

HYUNDAI BIOSCIENCE is a biotechnology company that develops drugs based on its novel drug delivery system technologies to deliver active ingredients safely and efficiently to targeted areas of the human body. Founded in 2000, Hyundai Bioscience focuses on repurposing or expanding indications of existing drugs using its proprietary organic-inorganic hybrid technologies. Hyundai Bioscience is a public company listed on the KOSDAQ (symbol: 048410) in South Korea.

For more information, please contact:
Mr. Joshua Kim, Managing Director, Hyundai Bioscience (planning@hyundaibio.com)