TFF Pharma: Inhaled Niclosamide Significantly Inhibits Viral Replication of Omicron

 Inhaled Niclosamide Demonstrates Potent Activity Against Omicron Variant

Dosing of Inhaled Niclosamide Estimated to Produce Concentrations in Excess of Effective Dose

Expecting to Complete Phase 1 Safety and Pharmacokinetic Data of Inhaled Niclosamide by End of 1Q’22

TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that results from its recently completed in vitro neutralization and viral replication assays indicate that the Company’s inhaled niclosamide product candidate completely inhibits viral replication of both the Delta and Omicron variants of SARS-CoV-2.

Compared to data from previously published studies, the results demonstrate that inhaled niclosamide appears to be the most potent inhibitor of SARS-CoV-2 replication, including the Omicron variant. More specifically, nirmatrelvir and molnupiravir each showed complete inhibition of the Omicron variant at 2.5 μM.1 In the studies announced today by TFF Pharmaceuticals, inhaled niclosamide demonstrated complete inhibition of Omicron at only 1μM. Results from these studies also confirm previous findings2 which validated the potent antiviral efficacy of niclosamide in a human airway model.

In a Phase 1 study, TFF Pharmaceuticals has already demonstrated that a 6 mg BID dosing of inhaled niclosamide is well tolerated. Importantly, the 6 mg dose level is estimated to produce a concentration of >100 μM in the epithelial lining fluid in the lung following delivery as a dry powder.

“The data demonstrating that niclosamide inhibits viral replication of the Omicron variant is proof of concept for the activity of the drug against SARS-CoV-2,” said Dr. Michael Saag, Professor of Medicine at UAB School of Medicine and Member of the TFF Pharmaceuticals Scientific Advisory Board. “Niclosamide’s mechanism of action, which inhibits human pathways involved in viral replication, restricts development of mutations in the viral genome. This results in much less opportunity for the emergence of resistance to drugs that target the virus. These exciting results further validate the approach that TFF is pursuing for treatment of respiratory infections by delivering a host-directed antiviral directly to the lung using a dry powder inhaler device. Additionally, the TFF niclosamide powder is temperature stable, enabling broad accessibility around the globe.”

https://finance.yahoo.com/news/tff-pharmaceuticals-announces-inhaled-niclosamide-142700333.html