UNION therapeutics A/S (UNION) announces expansion of the clinical pipeline with the addition of UNI91103 (intranasal niclosamide) to prevent COVID-19 and reduce the severity of the diseases among those already infected.

An alternative to vaccination in high-risk groups

Several high-risk patient groups do not respond well to vaccination suggesting a persistent need for alternative prophylactic measures. In response, UNION has expanded its clinical program for COVID-19 with a niclosamide based nasal spray (UNI91103) to prevent and alleviate infection among people at risk. UNI91103 will first be investigated in high risk patients to test its ability to prevent infection with COVID-19 and to reduce the severity of the disease for those already infected.

In addition, the nasal spray will be used in the treatment trials in combination with UNION’s inhalation product (UNI91104), which continues development for treatment of COVID-19. The nasal spray product, UNI91103, has been successfully tested in 44 healthy volunteers without significant safety concerns and is ready for tests in COVID-19 patients as well as subjects at risk of contracting COVID-19.

Maximizing the likelihood of prevention and treatment options

“The split of our COVID-19 program into two independent products for treatment and prevention of COVID-19 substantially increases the likelihood of bringing aid to patients and reducing societal impact” says Rasmus Toft-Kehler, CEO and co-founder of UNION.

Niclosamide was recently identified by Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19¹. Furthermore, niclosamide has been demonstrated to prevent fatal outcomes in a murine model of COVID-19 when administered intranasally².

Studies have documented that SARS-CoV-2 replicates most rapidly in the nasal epithelial cells and suggest that initial replication of the virus in the nasal cavity then leads to infection of the lungs. Sinonasal pathophysiology is increasingly important for our understanding of COVID-19, and the sinonasal tract is thought to be an important site for both infection as well as transmission³.

“The sinonasal cavity is an important site for the establishment and replication of SARS-CoV-2 in the early stages of COVID-19, accordingly we consider delivery of niclosamide directly to this site of early infection a key strategy for limiting the infection of people otherwise at risk for contracting COVID-19,” says UNION co-founder Professor Morten Sommer. UNION therapeutics expects to commence patient trials using UNI91103 in Q4 2020.

Sources

Jeon et al. AAC 2020, DOI: 10.1128/AAC.00819-20
Brunaugh et al. BiorXiv 2020, DOI: 10.1101/2020.09.24.310490
Gengler et al. Laryngoscope Investig Otolaryngol  2020, DOI: 10.1002/lio2.384

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