TFF Pharmaceuticals announced that a Phase 1 SAD/MAD study of its dry powder niclosamide found that inhalation of the formulation was well tolerated at all doses evaluated and that data from the study suggest moving into a Phase 2 study with a twice daily 6 mg dose. The company, which recently said that the dry powder niclosamide completely inhibited the Omicron variant of SARS-CoV-2 at a concentration of 1 μM in in vitro studies, estimated that the concentration of niclosamide in the epithelial lining fluid exceeded 100 μM following inhalation of a 6 mg dose.
Union Therapeutics acquired an option to license TFF’s niclosamide in August 2020. According to TFF, the Phase 1 study demonstrated that a single 6 mg dose of its dry powder formulation produced an equivalent Cmax as an inhaled 100 mg dose of an aqueous formulation of niclosamide currently in development at Union Therapeutics.
TFF Pharmaceuticals CEO Glenn Mattes commented, “We are very pleased to announce these positive safety and PK data for our niclosamide inhalation powder. While vaccines have played a vital role in addressing the COVID-19 pandemic, highly potent and safe antiviral therapeutics are clearly needed to combat this persisting virus. Given niclosamide’s potent activity across multiple variants including Omicron and the ability of the inhaled formulation to more directly target the site of infection in the lungs, we believe the positive safety and pharmacokinetic data announced today help position our niclosamide inhalation powder as a promising new treatment against COVID-19.”
Union Therapeutics Chief Operating Officer Rasmus Toft-Kehler said, “It is great to follow the progress and success of the TFF niclosamide inhalation powder program. The Phase 1 data coupled with the neutralizing effect of TFF niclosamide inhalation powder against Omicron and other variants demonstrate that this TFF product candidate, when delivered directly to the site of infection with a simple at-home pocket-sized inhaler, has potential to become an essential product for patients and prescribers in the ongoing fight against COVID-19.”
Read the TFF Pharmaceuticals press release.
