Hellerup, Denmark, June 16, 2023 – UNION therapeutics A/S, a privately-held, clinical stage, pharmaceutical development company focused on immunology and infectious disease, today announced topline results from the niclosamide arm of the PROTECT-V (PROphylaxis for paTIEnts at risk of COVID-19 infecTion) trial. This large randomized, double blind, placebo-controlled, event-driven platform study evaluated the use of niclosamide nasal spray as a pre-exposure prophylactic agent against COVID-19 infection.
The platform study, led by Cambridge University Hospital NHS Foundation Trust, the University of Cambridge in the UK and The George Institute for Global Health in India, has involved researchers and patients from across the UK and India. To date, it is the largest pre-exposure prophylaxis study conducted exclusively in a vulnerable renal patient population. Renal patients are often excluded from clinical trials and remain at risk of COVID-19 infection due to sub-optimal vaccine responses.
1,653 patients (1,233 from the UK and 420 from India) were randomized to either receive intranasal niclosamide or placebo for up to 36 weeks. Symptomatic COVID-19 infection was observed in 236 patients. The study did not meet its primary endpoint, as no difference was detected between risk of infection in the niclosamide and placebo groups. No major safety signals were reported in the study.
The results from the niclosamide arm of the PROTECT-V platform study were presented by Dr. Rona Smith, Chief Investigator of the PROTECT-V-study in the UK, in the late breaking clinical trials session at the 60th European Renal Association (ERA) Congress on June 16, 2023, in Milan, Italy.
Morten Sommer, Chief Scientific Officer of UNION therapeutics adds:
“We are pleased to have been part of the PROTECT-V platform study and are grateful for the commitment and dedication of patients, caregivers, investigators and funders who all have been instrumental in a very well-conducted study. The mechanistic rationale was sound, so we are of course disappointed that the study did not meet its primary endpoint.”
Contacts
UNION
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, mid- to late-stage, pharmaceutical development company advancing novel treatment options within immunology and infectious diseases, two large and fast-growing therapeutic areas. 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 http://www.uniontherapeutics.com
