Breakthrough in Long COVID: UCSD's IIT with Hyundai Bioscience's Xafty

SAN DIEGO, Sept. 17, 2024 -- Hyundai Bioscience USA has entered into a Memorandum of Understanding (MOU) with the University of California San Diego (UCSD) to conduct a researcher-led trial on Xafty®, an antiviral drug based on niclosamide, for the treatment of "Long-COVID". This trial will be overseen by UCSD Professor Ajay Bharti, who specializes in infectious diseases and clinical trials. Dr. Bharti's expertise in the neurocognitive impacts of viral diseases makes him an ideal candidate to lead this trial.

Professor Davey Smith, Director of the UCSD Altman Clinical and Translational Research Institute (ACTRI) and a recognized authority on viral diseases including COVID-19, remarked on the collaboration. He emphasized that Long-COVID affects millions globally and currently lacks effective treatment options.

Xafty is an oral antiviral medication that enhances the bioavailability of niclosamide, a compound known for its antiviral activity against over 30 viruses. The drug is presently undergoing a phase 3 clinical trial in Korea for high-risk COVID-19 groups and anticipates soon filing for phase 3 approval with the U.S. FDA. In earlier phase 2 trials, Xafty met the FDA’s primary endpoints, showing faster symptom improvement compared to existing treatments, especially among high-risk groups.

Dr. Smith, who has participated in numerous antiviral trials for diseases such as COVID-19, HIV, and Mpox, noted that Xafty’s ability to alleviate symptoms during acute COVID-19 is a notable achievement. This success could indicate the drug's potential effectiveness in treating Long-COVID as well.

Long-COVID is a multifaceted ailment believed to result from lingering virus, excessive inflammation, and subsequent nerve damage. Symptoms include chronic fatigue, inflammation, and cognitive issues. Current treatments target single mechanisms and fail to address the complex symptomatology, contributing to the lack of a definitive treatment for Long-COVID.

Xafty is designed to tackle the multifaceted symptoms of Long-COVID through mechanisms like inflammation inhibition and neuroprotection, beyond merely suppressing the virus. Niclosamide, the active ingredient in Xafty, is expected to offer therapeutic benefits by removing the virus, suppressing immune hypersensitivity, and aiding nerve recovery.

In a recent preclinical study on Parkinson's disease by Hyundai Bioscience, Xafty was shown to promote dopamine production and nerve cell recovery. When administered to a Parkinson's animal model with inhibited dopamine production, the drug resulted in higher dopamine levels compared to the group treated with Madopar®, a conventional Parkinson's medication. This suggests that Xafty could significantly alleviate symptoms such as brain fog and cognitive impairment in Long-COVID patients.

Dr. Ajay Bharti, the principal investigator of the study, highlighted that the broad-spectrum antiviral efficacy of niclosamide was already known. The decision to test Xafty for Long-COVID emerged after observing its excellent symptom improvement in a COVID-19 clinical trial, particularly in high-risk groups. The drug’s ability to recover neurons and boost dopamine production in a Parkinson's preclinical study was a crucial factor in initiating this clinical trial.

Dr. Smith added that the objective of the study is to validate that niclosamide can address the complex symptoms of Long-COVID through various mechanisms like virus suppression, inflammation reduction, and neuroprotection. He expressed hope that the trial would be successful, offering a practical treatment option for Long-COVID patients and marking a historic milestone in medical treatment.

About Hyundai Bioscience:
Hyundai Bioscience, established in 2000, is a biotechnology firm that focuses on developing drugs using innovative drug delivery system technologies to safely and efficiently target specific body areas. The company specializes in repurposing or extending the indications of existing drugs using its proprietary organic-inorganic hybrid technologies. Hyundai Bioscience is publicly traded on KOSDAQ (symbol: 048410) in South Korea.