UNION therapeutics A/S completes dosing of healthy volunteers with UNI911 (inhaled niclosamide) for COVID-19

• UNION has successfully completed inhalation dosing of 44 healthy volunteers, confirming the safety and tolerability of UNI911

• UNION has utilized many years of experience with niclosamide to develop UNI911, a proprietary salt form and formulation of niclosamide, for inhalation as a treatment candidate for COVID-19
• Delivery directly to the lung via inhalation allows UNION to address common challenges related to low bioavailability of oral niclosamide
• Niclosamide has been identified as a potent inhibitor of SARS-Cov-2 by Institut Pasteur Korea, with potency >40x higher than remdesivir¹
• UNION is preparing to advance UNI911 into COVID-19 patient trials

Hellerup, Denmark, August 25 2020 - UNION therapeutics A/S (“UNION”), a privately held, clinical stage pharmaceutical company, today announces the successful completion of dosing of 44 healthy volunteers with UNI911, an optimized salt form of niclosamide, as an inhalation treatment candidate for COVID-19.

The study was a double-blind, placebo-controlled, randomized study, where ascending single and multiple dosing regimens were given to 44 healthy volunteers by inhalation across five cohorts. The purpose of the study was to confirm the safety of UNI911 in preparation for a study to assess the safety and efficacy in patients with COVID-19.

UNI911 utilizes an optimized salt form of niclosamide, an existing compound identified as a potent inhibitor of SARS-Cov-2 by Institut Pasteur Korea, with potency >40x higher than remdesivir¹. Niclosamide has a well-established safety profile as an oral compound following decades of use as an anthelmintic drug. By delivering niclosamide salt form directly to the lungs through inhalation, high local exposures can be achieved and thereby resolve the common challenge of low oral bioavailability linked to niclosamide.

The Safety Monitoring Committee assessed the safety of UNI911 in each cohort before dose escalation in the next cohort was initiated. Successful completion of the five study cohorts provides basis for investigating UNI911 in COVID-19 patients.

“Finding treatment options for COVID-19 is of critical importance for the world, and UNI911 is a very interesting and differentiated candidate. The study confirmed that the drug is safe when administered by inhalation, which is a crucially important step in the development of any medicine. Delivering therapies via inhalation is widely used in respiratory medicine, particularly for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD), and delivering niclosamide by this means is looking very promising”, said Dr. Vibeke Backer, Clinical Professor at Rigshospitalet, Chairman of the Safety Monitoring Committee and National Coordinating Investigator on the study.

“Confirming the safety of UNI911 in healthy volunteers is a major milestone achieved in record speed, which has only been possible due to the extraordinary support and dedication of all involved parties. It provides further evidence that UNI911 is a uniquely differentiated candidate for prophylaxis and treatment of COVID-19. The team is now entirely dedicated to moving UNI911 into COVID-19 patients as rapidly as possible”, added Rasmus Toft-Kehler, CEO and co-founder of UNION.

The study in healthy volunteers was conducted in Denmark at the Zelo Phase I Unit at Bispebjerg and Frederiksberg Hospitals as well as Center for Physical Activity Research (CFAS) at Rigshospitalet, in collaboration with Trial Nation Denmark and the Technical University of Denmark, and with financial support from the Innovation Fund Denmark.

Contact
Morten Boesen
Chief Financial Officer
Tel: +45 2381 5487
Email: morten.boesen@uniontherapeutics.com

JW Communications
Julia Wilson
Tel: +44 781 8430877
Email: communications@uniontherapeutics.com

¹ Source: https://www.biorxiv.org/content/10.1101/2020.03.20.999730v2.full.pdf

About UNION:
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 and has three candidates in clinical development. UNION is headquartered in Hellerup (Denmark) and managed by an experienced team across Europe and USA. For more information please visit www.uniontherapeutics.com.

About UNI911 (inhaled niclosamide) in COVID-19
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. UNI911 is UNION’s lead program based on a proprietary salt form and formulation of niclosamide to be administered by inhalation. By delivering UNI911 directly to the lungs via inhalation addresses the challenges related to low bioavailability of niclosamide administered orally.

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