Trial Shows Inhaled Covid-19 Therapy Safe

(Wikimedia Commons)

6 Apr. 2021. Results of a clinical trial show an anti-microbial treatment for Covid-19 infections given as a nasal spray is safe and well-tolerated in healthy volunteers. The findings from a trial testing an inhaled version of the drug niclosamide, formulated as a nasal-spray therapy for Covid-19, appear in today’s issue of the journal The Lancet Regional Health – Europe.

Union Therapeutics A/S in Hellerup, Denmark develops treatments for inflammatory and infectious diseases, including Covid-19. Among the company’s therapy candidates is niclosamide, originally created as an anti-parasitic drug, which Union Therapeutics reformulates into an ointment for atopic dermatitis, also known as eczema, and is testing in a mid-stage clinical trial. The company points to data from a study in Korea published in June 2020, showing niclosamide as a particularly promising candidate, already approved by FDA, that acts against SARS-CoV-2 viruses responsible for Covid-19.

Union reconstitutes niclosamide as a treatment and vaccine against Covid-19 infections. The treatment candidate, code-named UNI91104, is formulated as a nasal spray, since an oral form of the drug dissipates in the blood stream before reaching the nasal passages and lungs where it can do the most good. The company says UNI91104 blocks replication of the SARS-CoV-2 virus, reduces inflammation, and helps open the airways, with results shown in preclinical tests with animals.

No more than mild adverse effects

The early-stage clinical trial, conducted by Union Therapeutics, enrolled healthy adult volunteers in Denmark. The study team tested various doses of UNI91104 nasal spray, looking primarily for any adverse effects from the drug, from one to seven days following the treatment. The paper reports on 44 participants, 34 receiving UNI91104 and 10 placebo recipients. The 34 recipients of UNI91104 were randomly assigned to receive one of four escalating doses in one day, or five doses of the drug in 2.5 days.

The results show only mild adverse effects from UNI91104 and no serious reactions to the drug. Of the volunteers, 26 reported mild and temporary upper-respiratory irritations. Tests of respiratory function given to participants show no evidence of difference between UNI91104 and placebo recipients. Blood tests of participants receiving UNI91104 show varying levels of the drug depending on dosage size, but no long-term accumulation.

Vibeke Backer, a pulmonologist at Rigshospitalet in Copenhagen, is the study’s principal investigator and first author of the paper. Backer notes in a Union Therapeutics statement that “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.”

Union Therapeutics is also testing its formulation of niclosamide as a preventative vaccine code-named UNI91103, but for more vulnerable patients. A clinical trial of UNI91103 is testing the vaccine among patients in the U.K. with kidney disorders, considered a high-risk population that may not respond to conventional vaccinations.

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