SAN
DIEGO, Sept. 17, 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.
For more information, please contact Ms. Joobin Jung, Global PR Manager
(joobin@hyundaibio.com).
View original content to download
multimedia:https://www.prnewswire.com/news-releases/breakthrough-in-long-covid-an-investigator-initiated-trial-iit-with-hyundai-biosciences-xafty-by-ucsd-302251155.html
SOURCE Hyundai Bioscience