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Phase 1 study of Union Therapeutics’ inhaled and intranasal niclosamide meets all endpoints

According to Union Therapeutics, a Phase 1 study of its UNI911 niclosamide solution met its primary endpoint, demonstrating “a strong safety profile” for both inhaled and intranasal delivery; the company said that the PK results were also encouraging. Union is developing the formulation for the prevention of COVID-19 (UNI91103) and for the treatment of COVID-19 (UNI91104). The results of the study were published online in The Lancet Regional Health – Europe.

The company’s PROTECT-V trial of UNI91103 in kidney patients recently received Urgent Public Health (UPH) prioritization in the UK.

Principle investigator Vibeke Backer of Rigshospitalet in Copenhagen, Denmark, commented, “UNI91103 and UNI91104 are exceptional because the products are administered locally by inhalation and intranasal administration. Hence, the poor bioavailability of niclosamide is addressed, enabling a high drug concentration in the area from which the COVID-19 infection otherwise starts to spread. In this way, inhaled drugs have been crucial in the management of other respiratory conditions such as asthma. Niclosamide is a relevant and important product that holds great potential for COVID-19, and it is rewarding to see this important data published in a peer-reviewed journal.”

Union Therapeutics Chief Scientific Officer Morten Sommer said, “With these promising results for safety and tolerance, the COVID-19 products of Union Therapeutics are gaining substantial interest from platform trials across the world.”

Read the Union Therapeutics press release.

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published on April 6, 2021

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