Inhaled Niclosamide Inhibits Viral Replication of the Omicron Variant of SARS-CoV-2

TFF Pharmaceuticals Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, announced on Feb. 24, 2022 that its inhaled niclosamide product completely inhibits viral replication of both the Delta and Omicron variants of SARS-CoV-2. This discovery came from the results of the company’s in vitro and viral replication assays.

The results demonstrate that inhaled niclosamide appears to be the most potent inhibitor of SARS-CoV-2 replication, including the Omicron variant. The results also confirm previous findings that validated the potent antiviral efficacy of niclosamide in a human airway model.

Niclosamide was originally approved for use as an oral anthelmintic drug by FDA in 1982. The drug has limited water solubility and low absorption and bioavailability when administered orally. TFF Pharmaceuticals intends to utilize its Thin Film Freezing technology to produce an inhaled formulation of niclosamide to directly target the lungs, where SARS-CoV-2 infection occurs. This approach would avoid gastrointestinal side effects and overcome the bioavailability limitations of systemic administration.

“These supportive data increase our confidence that inhaled niclosamide could become an important new therapeutic to combat COVID-19 infection,” said Glenn Mattes, CEO of TFF Pharmaceuticals, in the press release. “Inhaled niclosamide’s demonstrable potency at such low concentrations should enable us to deliver reduced doses of the drug directly to the lung without compromising antirviral activity, thereby conferring a major potential advantage with respect to safety and tolerability. As more pathogenic variants of the SARS-CoV-2 virus emerge, it is essential that potent antiviral therapies are available to help significantly reduce the morbidity and mortality associated with this infection, particularly in the most vulnerable populations who suffer from cardiopulmonary deficiencies.”

Source: TFF Pharmaceuticals