UNI91103, developed by UNION therapeutics A/S, selected as first agent for prophylactic COVID-19 "PROTECT-V" study in high-risk patients

- UNI91103 is a nasal spray delivering niclosamide - a potent inhibitor of SARS-CoV-2 with in-vitro potency >40x higher than remdesivir - to the nasal cavity

- UNI91103 has been selected as the first agent to be trialed in a study by UK investigators

- If successful, data generated will be used for registration of the product

- The study will include approx.1,500 kidney patients to assess if UNI91103 can prevent patients from contracting symptomatic COVID-19 and / or reduce serious illness and death from the infection

- Kidney patients are considered a high-risk patient population that may not respond well to vaccination

- Niclosamide has been demonstrated to prevent fatal outcomes in an animal model of COVID-19 when administered intranasally¹

HELLERUP, Denmark, Feb. 22, 2021 /PRNewswire/ -- UNION therapeutics A/S (UNION) has been selected by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge to trial UNI91103 (intranasal niclosamide) as a prophylactic treatment of COVID-19 in kidney patients, a vulnerable and high-risk patient population.

UNION has recently announced the expansion of its clinical program for COVID-19 with a niclosamide based nasal spray (UNI91103) to prevent and treat SARS-CoV-2 infection among people at risk. Kidney patients, in particular those on dialysis, are considered a particularly vulnerable patient population.

Following approval by the Medicines and Healthcare products Regulatory Agency (MHRA), the University of Cambridge has commenced recruitment to the PROphylaxis for vulnerable paTiEnts at risk of COVID-19 infecTion (PROTECT-V) trial.

A prophylactic treatment for vulnerable patients 
"Niclosamide, the active ingredient of UNI91103, was recently identified as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19, and is being developed by UNION for prevention and treatment of COVID-19," says UNION co-founder, Professor Morten Sommer².

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 lungs². When administered to the nasal cavity prior to exposure to SARS-CoV-2, UNI91103 would prevent the virus from establishing in the nasal cavity and spreading to the lungs.

"For high-risk patient groups such as dialysis patients, patients who have had a kidney transplant, and patients with auto-immune diseases requiring immunosuppressive medications, COVID-19 can be very serious. In fact, one in five kidney patients receiving dialysis in hospital or who have a kidney transplant, who tested positive for the virus, died within four weeks," explains Professor Morten Sommer³.

The fastest route to benefit patients
Funded by LifeArc, Kidney Research UK, the Addenbrooke's Charitable Trust, UNION therapeutics and further supported by the NIHR Cambridge Biomedical Research Centre, the clinical trial is expected to enroll at least 1,500 high-risk subjects. Initially, trial participants will be randomised to receive either a placebo drug or UNI91103, both provided by UNION therapeutics, in addition to their standard of care.

LifeArc has made £27m available to support the global effort against COVID-19, of which £10m has been given to repurpose existing medicines.

"Repurposing already available drugs or those in the late stage of development offers the fastest route to bring benefit to patients at this critical time," says LifeArc CEO, Melanie Lee.

A promising option
The trial, led by the Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge, involves researchers and patients from across the UK.

Dr. Rona Smith, who is leading the UK study, is senior research associate at the University of Cambridge and honorary consultant nephrologist at Addenbrooke's Hospital, says:

"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."

"The vaccine is a huge step forwards, but we know that the patients enrolled in this study may make less robust vaccine responses due to their underlying condition or treatment. Niclosamide may provide further protection against COVID-19 that doesn't rely on the immune system mounting a response," Dr Smith adds.

A persistent need for treatment and prevention
Currently a number of trials are taking place that are searching for an effective COVID-19 preventative treatment, but patients with impaired kidney function are largely excluded, despite being so vulnerable to the disease."Despite recent advancements with COVID-19 vaccines, UNION foresees a persistent need for prevention and treatment products targeting COVID-19. We are humbled and grateful for this extraordinary opportunity and look forward to collaborate with the PROTECT-V team to offer new prophylactic treatment options for some of the most vulnerable patients," says Kim Kjøller, CEO of UNION, and elaborates:

"The reason why this particular patient group may not respond well to vaccines is due to a low serological response caused by a weak immune defense system. The immune system of these patient groups is weak because of their illness and/or because of the treatment they are receiving. This is why the mortality rates among high-risk patients are so devastatingly high. At UNION we see an urgent need for contributing a potential solution to these patient groups as the global vaccination roll-out might not be the answer for several patient groups at risk."

Sources
1. Brunaugh et al. BiorXiv 2020, DOI: 10.1101/2020.09.24.310490
2. Jeon et al. AAC 2020, DOI: 10.1128/AAC.00819-20
3. Renal Registry, UK


For further information

Morten Boesen
Chief Financial Officer
Phone: +45 2381 5487
Email: info@uniontherapeutics.com
Website: www.uniontherapeutics.com

Marie-Louise Jersin
Communications Manager
Phone: +45 3049 4957
Email: mlj@szpirt.com

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 across immunology and microbiology and has multiple candidates in clinical development. UNION is headquartered in Hellerup (Denmark) and managed by an experienced, international team of pharmaceutical executives and biotech entrepreneurs. For more information please visit www.uniontherapeutics.com

About UNI91103

UNI91103 is a niclosamide based nasal spray in development for prophylaxis and treatment of COVID-19. SARS-CoV-2, the virus causing COVID-19, has been found to replicate most rapidly in nasal epithelial cells, and the sinonasal tract is thought to be an important site for infection as well as transmission. Niclosamide has been identified as a potent inhibitor of SARS-CoV-2 and has been demonstrated to prevent fatal outcomes in a murine challenge model of COVID-19 when administered intranasally. UNI91103 nasal spray is in development as a stand-alone product as well as in combination with UNION therapeutics' inhalation treatment product (UNI91104).

About Kidney Research UK

As the largest kidney research charity in the UK, nothing is going to stop us in our urgent mission to end kidney disease. We're here to be heard, to make a difference, to change the future. This is a disease that destroys lives. It must be stopped.
Over the past 60 years, our research has made an impact. But the incidence of kidney failure is rising, as are the factors contributing to it, such as diabetes and obesity. Today, we are more essential than ever. Kidney disease affects three million people in the UK, treatments can be gruelling and currently there is no cure. Only research will end this, and we are the ones to do it.
Find out more about our work: www.kidneyresearchuk.org 

About LifeArc

LifeArc is a self-funded medical research charity. Our mission is to advance translation of early science into health care treatments or diagnostics that can be taken through to full development and made available to patients. We have been doing this for more than 25 years and our work has resulted in a diagnostic for antibiotic resistance and four licensed medicines.

Our success allows us to explore new approaches to stimulate and fund translation. We have our own drug discovery and diagnostics development facilities, supported by experts in technology transfer and intellectual property who also provide services to other organisations. Our model is built on collaboration, and we partner with a broad range of groups including medical research charities, research organisations, industry and academic scientists. We are motivated by patient need and scientific opportunity. Two funds help us to invest in external projects for the benefit of patients: our Philanthropic Fund provides grants to support medical research projects focused on the translation of rare diseases research and our Seed Fund is aimed at start-up companies focused on developing new therapeutics and biological modalities. Find out more about our work on www.lifearc.org or follow us on LinkedIn or Twitter.

About Addenbrooke's Charitable Trust (ACT)

Registered charity number: 1170103
Our purpose is to raise funds to make Addenbrooke's and The Rosie hospitals even better through improved patient care that allows more people to be diagnosed quicker and more accurately, to get the treatment they need in environments that support health, and to recover more quickly or get the support that they need over and above what would be possible through NHS funding alone. With the help of many generous supporters, we provide funds so that your local hospitals can offer the very best care day after day, year after year.
For further information about Addenbrooke's Charitable Trust's work visit www.act4addenbrookes.org.uk or follow us on Twitter @ACTcharity.

About NIHR Cambridge Biomedical Research Centre

Based within the most outstanding NHS and University partnerships in the country, the Biomedical Research Centres are leaders in scientific translation. Located on the Cambridge Biomedical Campus, they receive substantial levels of funding from the National Institute for Health Research (NIHR) to translate fundamental biomedical research into clinical research that benefits patients and they are early adopters of new treatments.

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