TFF Pharmaceuticals has concluded subject enrolment in a Phase I clinical trial of a dry powder formulation of niclosamide to treat Covid-19 and other respiratory viral ailments.
A total of 40 healthy participants were enrolled in the trial. The company anticipates reporting full safety results from the trial later this quarter.
The trial comprised two phases, namely single ascending dose (SAD) and multiple ascending dose (MAD).
In the SAD phase of the trial, healthy subjects in three arms were given single inhalation doses of 0.5, 2, and 6mg.
Six subjects will be given active drug while two will receive a placebo.
The MAD phase consisted of 3 and 6mg doses given twice daily for 4.5 days.
No safety concerns or issues were found by the Safety Management Committee, which recommended the use of 6mg twice daily as safe for testing in the Phase II trial.
Union Therapeutics holds an option to exclusively licence the dry powder formulation of niclosamide based on Phase I trial data.
Following licencing, the company will oversee the next phase of the therapy development.
TFF Pharmaceuticals Clinical Development head Dale Christensen said: “We believe that our formulation of niclosamide will be able to be administered using an approved inhaler and acts directly at the primary site of infection, which we hope will show acceptable efficacy in the next phase of development now that we have completed enrolment in our Phase I safety study.
“Importantly, niclosamide targets human cell pathways rather than the SARS-CoV-2 virus itself, so it is not affected by mutations in the spike protein and could theoretically work against any emerging variant.”
An antiviral therapy, niclosamide is a SARS-CoV-2 inhibitor with potential activity against several variants of the virus.
The company plans to leverage its Thin Film Freezing technology to create the inhaled formulation of niclosamide, which can directly act on the lungs where Covid-19 infection occurs.