UNION therapeutics has reported that its Covid-19 candidates, inhaled and intranasal niclosamide (UNI91103 and UNI91104), showed a strong safety profile in a Phase I study, meeting the primary endpoints.
UNI91103 and UNI91104 are based on a proprietary salt form and formulation of niclosamide, which can be administered locally to the respiratory tract.
The randomised, placebo-controlled, double-blinded, multi-ascending dose trial enrolled 44 healthy subjects. They were grouped into five cohorts, where 34 individuals received UNI911 and ten subjects were given placebo.
According to the results, the trial met all its endpoints and showed that the concentrated niclosamide solution was well tolerated on administering intranasally and through inhaled route.
In the study, dose-proportional pharmacokinetic was observed with no indications of systemic accumulation of the drug in the blood.
UNION therapeutics chief scientific officer professor 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.”
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With this encouraging safety and pharmacokinetic results of inhaled and intranasal niclosamide, the company noted that the products will be analysed as a potential treatment (UNI91104) and prophylaxis (UNI91103) for Covid-19.
In a separate development, the National Institutes of Health (NIH) has selected NeuroRx’s Aviptadil as one of two drugs to be analysed in Phase III multi-center clinical trial to be conducted in the US as well as several countries.
In partnership with Relief Therapeutics, NeuroRx is developing Aviptadil as Zyesami.
Named ‘Therapeutics for Severely Ill Inpatients with COVID-19’ (TESICO), the trial is funded by the US Government COVID-19 Therapeutics Response and sponsored by NIH unit National Institute of Allergy and Infectious Diseases (NIAID).
Ir will enrol 640 subjects who will randomly receive Aviptadil or Remdesivir or a combination of both drugs or placebo.
Subject recovery from respiratory failure over 90 days will form the trial’s primary endpoint.
Last month, NeuroRx reported that the Phase IIb/III trial of intravenously administered Zyesami (aviptadil acetate) for treating respiratory failure in critically ill Covid-19 patients met the primary endpoint.