Breakthrough in Long COVID: An investigator-initiated trial (IIT) with Hyundai Bioscience's Xafty by UCSD

SAN DIEGO, Sept. 18, 2024 /PRNewswire/ -- Hyundai Bioscience USA announced that it has signed an MOU with the University of California San Diego (UCSD) to conduct an investigator-initiated trial to evaluate the efficacy of Xafty^®, a niclosamide-based antiviral developed by its Korean headquarters, in treating "Long-COVID". The trial will be led by UCSD Professor Ajay Bharti, an infectious disease specialist and clinical trialist. Dr. Bharti's particular expertise in the neurocognitive effects of viral illnesses make him perfectly suited to run the investigator initiated trial.

"This is an outstanding opportunity for UC San Diego and Hyundai Bioscience to partner together to tackle Long-COVID," Professor. Davey Smith, Director of the UCSD Altman Clinical and Translational Research Institute (ACTRI) of UCSD and an authority on viral illnesses, especially COVID, said about the collaboration. "There is no therapy currently available for the condition, which affects millions of people around the world."

Xafty, an oral antiviral agent, is a new drug that improved the bioavailability of niclosamide, which is known to have antiviral efficacy against more than 30 viruses. It is currently in a phase 3 clinical trial in Korea targeting high-risk groups for COVID-19 and is expected to apply for phase 3 to the U.S. FDA soon. In a previous phase 2 clinical trial, Xafty successfully met the FDA's primary endpoints, demonstrating a faster symptom improvement rate than other existing treatments, especially in high-risk groups.

"Being able to reduce symptoms during acute COVID-19 is an impressive accomplishment," Dr. Smith, who has helped run numerous antiviral trials in COVID-19, HIV, and Mpox, said. "Many large recent trials testing antivirals have not had such success. This may point to Xafty's effectiveness in Long-COVID as well."

Long-COVID is a complex disease that is suggested to be caused by residual virus, excessive inflammation, and consequent nerve damage. Patients suffer from various symptoms such as chronic fatigue, inflammation, and cognitive decline, but existing treatments rely on a single mechanism and fail to resolve these complex symptoms. This is one of the reasons why a clear treatment for Long-COVID has not yet been developed.

Xafty is expected to resolve the complex symptoms of Long-COVID through inflammation inhibition and neuro-protection mechanisms, rather than simply suppressing the virus. It is because niclosamide, Xafty's main pharmaceutical ingredient, is anticipated to provide practical therapeutic effects to patients through multiple mechanisms such as virus removal, suppression of immune hypersensitivity, and recovery of nerve damage.

In a recent Parkinson's disease preclinical study conducted by Hyundai Bioscience, Xafty demonstrated to promote dopamine production and nerve cell recovery. When Xafty was administered to a Parkinson's animal model with suppressed dopamine production, a higher dopamine level was confirmed than in the group administered with the existing Parkinson's disease treatment, dopamine precursor (Madopar^®), suggesting that it can make a significant contribution to improving symptoms such as brain fog and cognitive impairment due to nerve damage in people with Long-COVID.

Dr. Ajay Bharti, the PI of this study, said, "We already knew about the broad-spectrum antiviral efficacy of niclosamide, but after seeing data showing that Xafty, having improved the long-standing problem of bioavailability, showed excellent symptom improvement in a COVID-19 clinical trial, especially in the high-risk group, we came up with the idea of using the drug to treat Long COVID." He added, "In particular, the fact that Xafty recovered neurons in a preclinical study of Parkinson's disease and promoted dopamine production, resulting in higher dopamine levels than the control group that took Madopar^®, was an important trigger for this clinical study."

Dr. Smith added, "The goal of this study is to confirm that niclosamide can solve the complex symptoms of Long COVID through multiple mechanisms such as virus suppression, inflammation suppression, and neuroprotection. We hope that the clinical trial will be successful and provide a practical treatment option for Long COVID patients, which will be historic."

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 KOSDAQ (symbol: 048410) in South Korea.

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