According to TFF Pharmaceuticals, Health Canada has issued a no objection letter regarding a Phase 1 clinical trial of TFF’s dry powder inhaled niclosamide that will evaluate 0.5, 2, and 6 mg doses in healthy volunteers in the SAD phase and 3 and 6 mg doses twice a day for 5 days in the MAD phase. TFF said that it expects dosing to get underway in November 2021 and that enrollment should be completed early next year.
In August 2020, Union Therapeutics acquired an option to license rights to the dry powder formulation for the treatment of COVID-19. Earlier this year, Union announced that its UNI911 niclosamide solution, which it is developing in both inhaled and intranasal formulations for COVID-19, demonstrated “a strong safety profile” in a Phase 1 study.
TFF Pharmaceuticals CEO Glen Mattes commented, “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. 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.”
Union Therapeutics Chief Technology Officer Günter Ditzinger said, “We find the pre-clinical work by the TFF team encouraging and appreciate that Thin Film Freezing technology may offer an option to improve the delivery of niclosamide. The use of a dry powder inhaler could help to circumvent the poor oral bioavailability and significantly elevate the local exposure in lungs, the primary site of infection. We are looking forward to the results of the Phase 1 program and continuing the partnership with TFF Pharmaceuticals.”
Read the TFF Pharmaceuticals press release.
