Researchers from the University of Texas at Austin and Chungnam National University have published in vitro and in vivo data demonstrating that a dry powder formulation of niclosamide that includes human lysozyme (hLYS) as a carrier exhibits potent activity against both the MERS-CoV and SARS-CoV-2 viruses. The article is available as a preprint on BioRxiv and is awaiting peer review.
According to the researchers, the novel formulation would be suitable for delivery via nebulizer, nasal spray, or dry powder inhaler as a therapy for COVID-19. In addition to its activity against coronaviruses, the new niclosamide formulation also has the potential to offer protection against MRSA and inflammatory lung damage.
The niclosamide/hLYS formulation is created by spray drying, a widely available technology, and was designed by a different laboratory than a thin film freezing (TFF) formulation of niclosamide that was also created at UT Austin and which is in Phase 1 development as a possible DPI for COVID-19. The new formulation is also available for licensing.
UT Austin graduate research fellow Ashlee Brunaugh said, “We have demonstrated that administration of niclosamide-lysozyme particles to the airways of mice with established, lethal SARS-CoV-2 infection improves survival, greatly reduces lung tissue damage, and significantly reduces viral loads in the lungs, brain, and kidneys. The formulation was designed in such a way that it can be administered to patients across the spectrum of COVID-19 severity, which may range from mild or asymptomatic disease to respiratory failure requiring mechanical ventilation. We believe that this will enable more widespread utilization and based upon our promising initial results, we are very excited to move onto additional studies that will propel our niclosamide formulation into the clinic.”
UT Austin Professor Hugh Smyth noted that the formulation can be manufactured quickly and cost effectively at scale and added, “This composition of niclosamide showed potent antiviral effects after intranasal administration in challenging models of coronavirus infections. These results were exciting for us because the therapy can be administered to the lungs and/or nasal cavity. The upper respiratory tract appears to be the primary site of infection for COVID-19.”
Read the University of Texas at Austin announcement.
