- The PROTECT-V Phase 2/3 platform study investigating niclosamide nasal spray as prophylactic treatment for COVID-19 in kidney patients will now be conducted in both the UK and India
- UK investigators have enrolled over 1000 patients in the study across the UK, and with the expansion of the study to India, the study will be further strengthened, and the conclusion potentially accelerated
- A significant unmet medical need persists to protect kidney patients, as well as other immunocompromised patients, as they may not respond sufficiently to COVID-19 vaccination
Hellerup, Denmark, 30 March 2022 – UNION therapeutics A/S, a privately held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases, announces that the first patient in India has been enrolled in PROTECT-V, a Phase 2/3 study evaluating niclosamide nasal spray as a prophylactic agent against COVID-19 infection.
In the UK, PROTECT-V is a nationally prioritized platform study sponsored by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge. In India, the sponsor of the study is The George Institute for Global Health India with Professor Vivekanand Jha as Chief Investigator. The PROTECT-V study in India will only contain the niclosamide nasal spray arm of the study.
Professor Vivekanand Jha, Chief Investigator of the PROTECT-V study in India said:
“There are many patients with advanced kidney disease including those on dialysis, kidney transplant recipients or those receiving immunosuppressive medications for their kidney disease. These individuals are at high risk for contracting COVID-19, both due to their immunocompromised condition, but also because the immune response of the COVID-19 vaccination in these patients is often suboptimal and wanes rapidly. Therefore, there is a need for an additional preventative strategy to safeguard the health of millions of people with these conditions in India.”
Dr. Rona Smith, Chief Investigator of the PROTECT-V study in the UK, is a senior research associate at the University of Cambridge and honorary consultant nephrologist at Addenbrooke’s Hospital, says:“Despite the successful roll out of vaccinations against COVID-19, there remains an ongoing medical need for pre-exposure prophylaxis in vulnerable patient populations, including those with kidney disease, who often mount sub-optimal responses to vaccination. Intranasal niclosamide is the first agent to be trialed in the PROTECT-V platform, and the international collaboration with Professor Jha and his team at The George Institute for Global Health is an exciting development in the evolution of this study.”
Kim Kjøller, Chief Executive Officer of UNION therapeutics said:“We are very honored that Professor Vivekanand Jha has shown an interest in the PROTECT-V study and the support given to extend the study to India. This validates the potential for niclosamide as a prophylactic treatment of COVID-19. A successful outcome of the study is expected to lead to an application for registration of niclosamide nasal spray as a prophylactic treatment for kidney and immunocompromised patients.”
About the PROTECT-V Phase 2/3 study
The Phase 2/3 study is a randomized, double blind, placebo-controlled, event-driven study evaluating the use of niclosamide nasal spray as a prophylactic agent against COVID-19 infection. 1500 patients are expected to be enrolled in the study in the UK and 750 patients in India. Participants in the study are vulnerable, high-risk immunocompromised patients: dialysis patients, kidney transplant recipients and those with vasculitis or other autoimmune kidney disease/glomerulonephritis (GN).
The aim of the study is to determine whether the niclosamide nasal spray reduces the risk of confirmed symptomatic COVID-19 infection in kidney and immunocompromised patients.
UNION has developed a concentrated liquid formulation of niclosamide that allows for delivery as a nasal spray to the upper respiratory tract. For respiratory infections such as COVID-19, this allows for a local delivery of niclosamide directly to the site of infection, either as a potential treatment or, prior to infection, as a prophylactic agent. 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.
Morten Boesen, Chief Financial Officer, UNION therapeutics A/S
+45 2381 5487
Sarah Toft-Jørgensen, Director of Communications and IR, UNION therapeutics A/S
+45 5385 3044
About UNION therapeutics
UNION therapeutics is a privately held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with multiple candidates in clinical development. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and seasoned pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at www.uniontherapeutics.com