Hyundai Bioscience (CEO Sang-gi Oh) announced on the 19th that the research team led by Professor David Smith at the University of California San Diego (UCSD) has decided to conduct a researcher-initiated clinical trial on long COVID using Xafty.
Long COVID, also known as chronic COVID-19 syndrome, is characterized by the persistence of the virus in the body after COVID-19 infection, causing symptoms such as cough, sputum, and loss of smell and taste. The virus that has penetrated the body damages nerve cells, leading to decreased dopamine secretion in nerve cells and resulting in brain fog (severe cognitive and concentration impairment). Additionally, immune system disruption causes autoimmune symptoms such as shortness of breath, fatigue, and lethargy.
According to the World Health Organization (WHO), at least 65 million people worldwide suffer from long COVID, and the U.S. Centers for Disease Control and Prevention reports that 8.9% (1 in 11) of American adults aged 18 and older have long COVID. Despite this, even four years after the COVID-19 pandemic began, there is still no adequate treatment for long COVID.
To effectively treat long COVID, a drug must simultaneously address the three main causes: elimination of residual virus in the body, recovery of virus-damaged nerve cells, and correction of immune system disruption. Currently, some drugs are undergoing clinical trials for long COVID in the U.S. and elsewhere, but all these drugs have limitations in that they cannot solve these three problems simultaneously.
On the other hand, Xafty is described as a drug with the potential to overcome the three main causes of long COVID. Clinical trials for COVID-19 have demonstrated that Xafty rapidly reduces the COVID-19 virus within 16 hours of administration and improves 12 COVID-19 symptoms. Recent animal experiments using a Parkinson’s disease model confirmed that it promotes recovery of damaged nerve cells and stimulates dopamine production.
Furthermore, niclosamide, the main ingredient of Xafty, was identified as the most effective anti-inflammatory drug among 2,560 drugs and has been found to suppress excessive activation of immune-related proteins caused by the COVID-19 virus and prevent resulting organ damage.
However, niclosamide had not been repurposed as a drug due to its low bioavailability. Xafty, through patented drug delivery technology, improves the 'low bioavailability' issue and has been repurposed as a therapeutic agent. Currently, a Phase 3 clinical trial targeting high-risk COVID-19 patients is underway in South Korea, and a Phase 3 application will soon be submitted to the U.S. FDA.
Professor Smith, who leads this researcher-initiated clinical trial, is the director of the Altman Clinical and Translational Research Institute (ACTRI) at UCSD School of Medicine. He served as co-chair of the international protocol for the ACTIV-2 treatment study, part of the U.S. government’s response to find treatments at the onset of the COVID-19 outbreak. He is recognized as a top 1% researcher worldwide by citation count in 2022 and 2023 and is an authority on HIV, COVID-19, mpox, and long COVID research.
Dr. Ajay Bharti, a professor affiliated with ACTRI and the Principal Investigator (PI) of this researcher-initiated clinical trial, is an infectious disease expert conducting multiple projects funded by the U.S. National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute of Mental Health (NIMH).
The company stated three reasons why Professor Smith’s team selected Xafty as the drug for the long COVID researcher-initiated clinical trial. First, Xafty, which overcomes the low bioavailability issue of niclosamide?known for its antiviral and anti-inflammatory effects in cell experiments?has demonstrated antiviral efficacy and consequent anti-inflammatory effects in humans for the first time through COVID-19 clinical trials. Second, since long COVID requires long-term treatment, safety must be confirmed for prolonged use, and Xafty’s safety was proven in a 13-week animal toxicity study. Third, Parkinson’s disease animal experiments showed that Xafty promotes recovery of damaged neurons and dopamine production, suggesting a high potential to improve major long COVID symptoms such as nerve damage, brain fog, and cognitive impairment.
Professor Smith said, "The goal of this researcher-initiated clinical trial is to confirm that Xafty can address the complex symptoms of long COVID through multiple mechanisms, including niclosamide’s antiviral, anti-inflammatory, and neuroprotective effects." He added, "We expect Xafty to be a historic breakthrough in the treatment of long COVID."
Hyundai Bioscience Vice President Heung-jung Woo said, "It was very disappointing that a researcher-initiated clinical trial for long COVID using Xafty was attempted but failed in Korea. However, it is deeply moving that world-renowned experts in the U.S. have recognized Xafty’s efficacy and started a researcher-initiated clinical trial for long COVID." He added, "We hope this research will bring hope to patients suffering from long COVID worldwide."
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