Hyundai Bioscience's Covid-19 treatment, Xafty, is significantly more effective than other Covid-19 drugs, according to a recent study.
Hyundai Bioscience announced on Monday that the results of a clinical trial evaluating the safety and efficacy of Xafty in 300 mild to moderate Covid-19 patients have been confirmed. The analysis was conducted by a research team led by Professors Choi Jun-yong and Kim Jung-ho of the Department of Infectious Diseases at Severance Hospital.
The research team noted that currently approved oral Covid-19 treatments, including Paxlovid, Lagevrio, and Xocova, have limitations, such as drug interactions, potential teratogenicity, and reduced efficacy in vaccinated individuals. They scientifically validated whether Xafti, which contains niclosamide as its main ingredient and has been confirmed to be safe and effective against 33 strains of 16 viral families, is a safer and more effective drug than existing approved treatments.
As a result, Xafti, a Covid-19 treatment developed by repurposing niclosamide using nano-hybrid technology to enhance its low bioavailability, was confirmed through clinical trials to be safe with no safety concerns and significantly more effective than other approved treatments.
In an analysis of patients who received treatment within three days of symptom onset, the low-dose group (300 mg) reduced the number of days required for improvement of 12 Covid-19 symptoms by 3.5 days compared to the placebo group, while the high-risk group reduced the number of days by five days compared to the placebo group.
The research team analyzed that Xafti's efficacy is superior to that of Paxlovid, which reduced the time required for symptom improvement by three days in the high-risk group, and Xocova, which reduced the time required for improvement of five symptoms by one day in the general-risk group.
Additionally, the research team presented a different rationale regarding the reason cited by the Ministry of Food and Drug Safety (MFDS) for rejecting Xafti's clinical trial (phase 2/3) plan approval application in April, which was that “statistically significant results for symptom improvement were not observed in the high-dose group.”
The reason why statistically significant results for symptom improvement were not observed in the high-dose group compared to the low-dose group in Xafti's clinical trial was simply because the magnesium oxide (MgO) content in the test drug administered to the high-dose group (450 mg) was higher than that in the test drug administered to the low-dose group (300 mg).
The research team explained that this finding is supported by post-hoc analyses that excluded the influence of MgO, which showed that the time to improvement of the representative symptoms of Covid-19, including fever, headache, and sore throat, as statistically significantly shorter in both the low-dose and high-dose groups.
In the clinical trial results for Xafty, the drug reduced the amount of Covid-19 virus by 13.8 times in the low-dose group and 13.5 times in the high-dose group compared to the placebo group within 16 hours after administration. In contrast, Paxlovid reduced the amount of the Covid-19 virus by 10 times compared to the placebo group by day five after administration, and Xocova reduced the amount of the Covid-19 virus by a statistically significant amount by day four.
The research team analyzed Xafti's rapid suppression of the Covid-19 virus, which could contribute not only to alleviating acute symptoms but also reducing tissue damage and the risk of post-infection complications.
“The publication of this paper acknowledges that Xafti, unlike conventional antiviral drugs that directly target the virus, is the first antiviral drug with a novel host-targeted mechanism of action that normalizes cellular autophagy, enabling cells to eliminate viruses that have penetrated them directly,” Professor Choi said. “This is significant because Xafti demonstrated both safety and rapid symptom improvement, as well as a reduction in viral load.”
Co-author Chair Professor Choy Jin-ho of Dankook University College of Medicine noted, "Due to its extremely low solubility and bioavailability, niclosamide has not been clinically tested in humans for over 40 years. By integrating nano-hybrid technology to address niclosamide's long-standing challenges, Xafti's clinical results have demonstrated, for the first time in human trials, that niclosamide possesses a platform mechanism of action as a broad-spectrum antiviral agent. All viruses expected to cause future pandemics are respiratory viruses. We are confident that Xafti will become a core therapeutic agent for preparing against future pandemics."