View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
January 28, 2022

TFF Pharma concludes enrolment of Phase I inhaled Covid-19 treatment trial

Based on results from the trial, Union Therapeutics holds an option to licence the dry powder formulation of niclosamide.

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. 

Related Companies

Free Whitepaper
img

Unlocking the clinical trial potential of Africa

Ongoing improvements around infrastructure, continued investment, and being home to one of the world’s largest working age populations, means that Africa’s role in the clinical trials market has transformed. In this whitepaper, Oximio outlines the dynamics of today’s clinical trial market in Africa, including the key challenges the region is facing and how sponsors can overcome them to unlock the continent’s growing potential.
by Oximio
Enter your details here to receive your free Whitepaper.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU