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 it has received approval from Health Canada to begin a Phase 1 clinical trial of a dry powder formulation of niclosamide, an antiviral treatment with potential to address COVID-19 and other infectious diseases.
The Phase 1 study was cleared by Health Canada via a No Objection Letter (NOL) received on October 22, 2021. TFF Pharmaceuticals anticipates the first patient will be dosed in the study in November and that enrollment will be completed by early Q1 2022.
“Early on in the COVID-19 pandemic, niclosamide was identified as a highly promising option for treating severe COVID-19 because of its ability to inhibit cellular processes in the human cell that are required for SARS-CoV-2 replication, thereby inhibiting the production of new viral particles from infected cells,” said Glenn Mattes, CEO of TFF Pharmaceuticals. “Our inhaled niclosamide powder, developed via TFF’s unique Thin Film Freezing technology platform, has been shown to reduce COVID-19 viral load in vivo and offers both direct delivery to the site of infection in the lung and more convenient outpatient administration compared to the IV administered approved antibody COVID-19 treatments. We believe that our preclinical results for inhaled niclosamide will translate to positive outcomes in humans and look forward to initiating the study.”
“Inhaled niclosamide presents a potentially game-changing solution to addressing ongoing cases of COVID-19, combining a known potent antiviral against SARS-CoV-2 with TFF’s Thin Film Freezing technology to allow direct delivery to the lungs,” said Jay Peters, M.D., Chief of Pulmonary and Critical Care Medicine at the University of Texas Health Science Center at San Antonio and a member of TFF’s Scientific Advisory Board. “Inhaled niclosamide could also serve as an essential treatment for other infectious diseases that affect the lungs. I look forward to seeing the results of the upcoming clinical trial.”
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