Hyundai Bioscience and the University of California San Diego (UCSD) are partnering in an investigator-initiated trial (IIT) to study the efficacy of Xafty, an oral antiviral drug, for the treatment of Long COVID. The trial, led by UCSD Professor Ajay Bharti, will evaluate Xafty's ability to address the complex symptoms of Long COVID, a condition affecting millions worldwide for which there is currently no approved therapy.
Xafty: A Novel Approach to Long COVID
Xafty is a reformulated version of niclosamide, designed to improve its bioavailability. Niclosamide has demonstrated antiviral activity against a broad spectrum of viruses. Xafty is currently in Phase 3 clinical trials in Korea for high-risk COVID-19 patients and is preparing for a U.S. FDA Phase 3 application. Previous Phase 2 trials have shown that Xafty achieved faster symptom improvement compared to existing treatments, particularly in high-risk groups.
"Being able to reduce symptoms during acute COVID-19 is an impressive accomplishment," said Dr. Davey Smith, Director of the UCSD Altman Clinical and Translational Research Institute (ACTRI). "Many large recent trials testing antivirals have not had such success. This may point to Xafty's effectiveness in Long-COVID as well."
Addressing the Complexities of Long COVID
Long COVID is characterized by a range of persistent symptoms, including chronic fatigue, inflammation, and cognitive decline. These symptoms are believed to stem from residual virus, excessive inflammation, and nerve damage. Current treatments often target single mechanisms, failing to comprehensively address the multifaceted nature of the condition. Xafty's developers believe that niclosamide can target multiple mechanisms to resolve the complex symptoms of Long COVID.
Preclinical Evidence Supports Neuroprotective Effects
Preclinical studies in a Parkinson's disease model have indicated that Xafty can promote dopamine production and nerve cell recovery. In these studies, Xafty administration led to higher dopamine levels compared to treatment with a dopamine precursor (Madopar), suggesting potential benefits for cognitive impairment and brain fog associated with Long COVID.
"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," Dr. Bharti stated. "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."
Trial Goals and Potential Impact
The IIT aims to confirm that niclosamide can address Long COVID symptoms through virus suppression, inflammation reduction, and neuroprotection. Researchers hope the trial will yield a practical treatment option for Long COVID patients.
"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," Dr. Smith added.
