- The Lancet Regional Health - Europe has published the results of UNION therapeutics’ phase 1 study of inhaled and intranasal niclosamide products (UNI91103 and UNI91104)
- The study endpoints were to assess the safety profile and the pharmacokinetic profile of niclosamide when administered as a nasal spray and as an inhalation product (nebulizer)
- The study was placebo-controlled and conducted in healthy volunteers
- No adverse effects were identified, paving the way for further investigation in COVID-19 patients
- On the basis of these results UNI91103 has been selected as the first intervention of the PROTECT-V study, which recently received UK Urgent Public Heath prioritization
Hellerup, Denmark, April 6, 2021 – UNION therapeutics A/S (UNION) announced today that the results of a phase 1 study of inhaled and intranasal niclosamide (UNI911) have been published by The Lancet Regional Health – Europe (LINK). With no serious adverse effects reported, the study showed a strong safety profile of inhaled and intranasal niclosamide which was the primary endpoint for the trial.
The promising safety and pharmacokinetic results for inhaled and intranasal niclosamide have opened the doors for further investigation, and will now be tested as a potential treatment (UNI91104) and prophylaxis (UNI91103) for COVID-19. Niclosamide was shown by Institut Pasteur to have a 40-fold better potency than remdesivir against SARS-CoV-2.
Local administration of niclosamide prompts new options for the treatment of COVID-19
Professor Vibeke Backer, pulmonologist at the Center for Physical Activity Research, at Rigshospitalet, Copenhagen, served as principal investigator for the phase 1 study. Professor Backer has taken the lead on the Lancet Regional Health Europe paper.
“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,” Dr Backer said.
The phase 1 trial described in the publication was randomized, placebo-controlled, double-blinded, multi-ascending dose, and was conducted in 44 healthy volunteers, of which 34 were assigned to UNI911 and 10 to placebo across five cohorts.
The trial was conducted with DanTrials at Bispebjerg Hospital, Copenhagen, backed by experts from Rigshospitalet and supported financially by the Innovation Fund Denmark.
Local administration of niclosamide to the nasal cavity and the lungs was well tolerated
The phase 1 trial met all its endpoints and demonstrated that the concentrated niclosamide solution of UNION therapeutics is well tolerated when administered via the intranasal and inhaled route. The study results demonstrated a dose-proportional pharmacokinetic and showed no signs of systemic accumulation of the drug in the blood.
“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,” said Professor Morten Sommer, Chief Scientific Officer at UNION therapeutics.
A promising prophylactic option for vulnerable patients
UNION therapeutics recently announced that UNI91103 will be tested in kidney patients, a particularly high-risk patient population. Led by Cambridge University and funded by among others Kidney Research UK, the PROTECT-V study is set to determine if UNI91103 could work as a preventive treatment for kidney patients who may not benefit sufficiently from vaccinations alone.
“Finding effective agents for treatment and prophylaxis is crucial for our ability to manage COVID-19 infection. We identified niclosamide as a promising option, and we look forward to testing it in this very critical patient population,” said Dr Rona Smith in connection to the announcement of the PROTECT-V trial. Dr Smith, who is leading the study, is senior research associate at the University of Cambridge and honorary consultant nephrologist at Addenbrooke’s Hospital.
The PROTECT-V trial recently received Urgent Public Health Prioritization from the UK government ensuring rapid roll out across the UK.
The Lancet Regional Health - Europe is a regional edition of the Lancet that focuses on research conducted in the European Region.
1: Source: https://www.biorxiv.org/content/10.1101/2020.03.20.999730v2.full.pdf
About UNI91103 and UNI91104
Recent studies undertaken by the Institut Pasteur Korea, an infectious disease-focused research institute, have identified niclosamide as one of the most potent inhibitors of SARS-CoV-2; the virus causing COVID-19 based on in vitro studies. Niclosamide has the potential to become a truly differentiated treatment of COVID-19, effectively blocking replication of SARS-CoV-2 by targeting host cells to disrupt the viral life cycle. UNION has more than six years of preclinical and clinical experience with niclosamide and has utilized these insights to advance a battery of potential niclosamide-based treatments for COVID-19. UNI91103 and UNI91104 are two products developed by UNION based on a proprietary salt form and formulation of niclosamide to be administered locally to the respiratory tract. By delivering niclosamide directly to the lungs and the nasal cavity UNI91103 and UNI91104 addresses the challenges related to low bioavailability of niclosamide administered orally.
About UNION therapeutics A/S
UNION therapeutics A/S is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. The Company is working on two complementary chemistry classes spanning immunology and microbiology, with multiple candidates in clinical development. UNION is headquartered in Hellerup (Denmark) and is managed by an experienced international team. For more information, please visit: www.uniontherapeutics.com.
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