Inhalable Therapy for COVID-19 Needs Support

A team of University of Texas (UT) researchers is developing an inhalable therapy for treating COVID-19 patients, but the research needs further funding to go to clinical trials.

UT Pharmacy professor Hugh Smyth said in a press statement published on October 6, 2020, the treatment uses the drug niclosamide, which was originally used to treat intestinal worms. 

Ashlee Brunaugh, a pharmacy graduate student in Smyth’s lab, added niclosamide has been demonstrated to work well against COVID-19, but the existing oral tablet does not have enough of the drug to be effective. The UT team made an inhalable form that directly targets the lungs, where the coronavirus infection primarily occurs.

Brunaugh said the team chose the nasal spray and the dry powder inhaler for the treatment because the receptors for the virus that causes COVID-19 are found in both the nose and the lungs.

Brunaugh said among the mice treated with the new formulation, the ones infected with MERS-CoV, which causes Middle East respiratory syndrome, had a 43 percent survival rate, and the mice infected with SARS-CoV-2, which causes COVID-19, had a 30 percent survival rate.

“We can deliver it by nasal spray, a device called the dry powder inhaler — which is a really small portable device — or a nebulizer, which is what doctors typically use to deliver the drug to patients on a ventilator,” Brunaugh said.

Brunaugh said the team found the formulation to work well in cell cultures in vitro and when administered to mice with a coronavirus infection in vivo. 

“The clinical situation right now is that most of these patients are already going to have the virus, and the infection is established when they go for treatment,” Brunaugh said. “So it makes more sense to do all of the in vitro and in vivo studies in established infections.”

The UT team collaborated with professor Sang Heui Seo at Chungnam National University in South Korea to use a biosafety level 3 lab for these experiments. Biology senior Hyojong Seo, who worked on the experiments, said the mice had a human gene that allowed them to be infected with coronaviruses.

“In terms of being able to scale (niclosamide), we can do that rather rapidly because, first of all, there's a lot of bulk drug around, and secondly, the drug has also been well studied from a safety point of view, and that makes it more amenable to quickly getting into clinical trials,” Smyth said. 

The UT team needs more funding to be able to run the safety studies with their specific formulation at a level the US Food and Drug Administration would accept, which would be necessary to file an investigational new drug application.

“Once you start making drugs for human use in clinical trials, you need to manufacture on a much larger scale than what we are capable of doing, and you also need to make sure you're manufacturing it in a way that is very sterile and safe,” Brunaugh said. “So in that case, we really need a partner for the industry to move us forward.”

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