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UNION therapeutics announces enrollment of first patient in the PREVENT study evaluating niclosamide in COVID-19 infected patients

  • PREVENT1) is an exploratory Phase 2 study of niclosamide nasal spray (UNI91103) in asymptomatic or mildly symptomatic COVID-19 infected patients
  • UNI91103 is a potent inhibitor of SARS-CoV-2 with in-vitro potency >40x higher than remdesivir2)

Hellerup, Denmark, 22 October 2021 – UNION therapeutics A/S, a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, today announced the enrollment of the first patient in PREVENT, a Phase 2 randomized, placebo-controlled double-blind study in COVID-19. The primary objective of this study is to investigate if intranasal niclosamide can prevent development and halt progression of symptoms in participants who are infected with COVID-19 but have either no or only mild symptoms upon enrollment.

PREVENT is the first study of intranasally administered niclosamide in COVID-19 infected patients. UNI91103 is currently also being tested as experimental prophylactic agents in immunocompromised individuals who may require additional protection from COVID-19 in addition to vaccination (PROTECT-V). Studies in COVID-19 patients follow promising safety and pharmacokinetic results for intranasal and inhaled (UNI91104) niclosamide in a Phase 1 trial published in the Lancet.3)

Per Cantor, Chief Medical Officer of UNION therapeutics said:
“This is the first time we study our UNI91103 nasal spray for early virus intervention in patients. Niclosamide has the potential to become a truly differentiated therapeutic for prevention and treatment of COVID-19 infection and potentially other respiratory infections. Building on the positive safety findings in the Phase 1 trial with intranasal and inhaled niclosamide, and studies by Institut Pasteur Korea identifying niclosamide as one of the most potent inhibitors of SARS-CoV-2, we look forward to further advancing niclosamide in clinical trials.”

About the PREVENT study
UNION has designed a program to test niclosamide in different stages of the disease, ranging from prophylaxis to treatment based on preclinical efficacy data of niclosamide and supportive findings from the Phase 1 study. The PREVENT study is designed to test whether intranasal niclosamide (UNI91103) administered twice daily over a 10-day period can serve as an early intervention and halt progression of symptoms in participants who are infected with COVID-19 but have either no or only mild symptoms upon enrollment. The trial also aims to determine if UNI91103 reduces the rate of hospitalization due to COVID-19, dissemination of COVID-19 to household contacts and the COVID-19 viral load. The study will initially be conducted at multiple sites in Germany.

COVID-19 platform trials with niclosamide
UNION’s aerosolized niclosamide products have been selected for leading international platform trials in COVID-19 and is being tested in multiple COVID-19 disease stages. In the PROTECT-V platform study, niclosamide nasal spray is currently being investigated as prophylaxis in patients at risk of COVID-19 infection, such as patients on dialysis, with kidney transplant or with vasculitis/glomerulonephritis. The study is led by the Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge.

About niclosamide in COVID-19
In March 2020, studies undertaken by Institut Pasteur Korea identified niclosamide as one of the most potent inhibitors of SARS-CoV-2; the virus causing COVID-19 based on in-vitro studies4). UNION has more than six years of preclinical and clinical experience with niclosamide and has utilized these insights to advance several niclosamide-based treatments for COVID-19. UNI91103 (nasal spray) and UNI91104 (nasal spray and nebulizer) are two proprietary products developed by UNION based on niclosamide for local administration to the respiratory tract. By delivering niclosamide directly to the lungs and the nasal cavity, UNI91103 and UNI91104 circumvents low bioavailability of niclosamide administered orally. UNI91103 has been selected as a “Priority 1” candidate for COVID-19 by Airfinity and ranks among 1 of 13 antiviral candidates in development.5)

Contacts

UNION therapeutics A/S
Morten Boesen, Chief Financial Officer
+45 2381 5487
[email protected]

Media enquiries

UNION therapeutics A/S
Sarah Toft-Jørgensen, Director of Communications and IR
+45 5385 3044
[email protected]

Sources:

  1. ClinicalTrials.gov identifier (NCT number): NCT04932915
  2. https://journals.asm.org/doi/full/10.1128/AAC.00819-20
  3. https://www.sciencedirect.com/science/article/pii/S2666776221000715
  4. https://www.biorxiv.org/content/10.1101/2020.03.20.999730v2.full.pdf
  5. Airfinity; Priority 1 is defined by Airfinity as: “Candidates that have/are expected to report positive late phase randomized trial results that have received regulatory approval”

 

About UNION therapeutics
UNION therapeutics is a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with seven programs in clinical development. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and senior pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at www.uniontherapeutics.com

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