niclosamide nasal spray (UNI91103) / UNION Therap, Institut Pasteur Korea - LARVOL DELTA

PROTECT-V: PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V (clinicaltrials.gov) - P2/3 | N=2240 | Completed | Sponsor: Cambridge University Hospitals NHS Foundation Trust | Recruiting ➔ Completed | N=5000 ➔ 2240 | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Jul 2024 ➔ Apr 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

PROTECT-V: PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V (clinicaltrials.gov) - P2/3 | N=5000 | Recruiting | Sponsor: Cambridge University Hospitals NHS Foundation Trust | Trial primary completion date: Jul 2023 ➔ Jul 2024

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

PROTECT-V: PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V (clinicaltrials.gov) - P2/3 | N=5000 | Recruiting | Sponsor: Cambridge University Hospitals NHS Foundation Trust | N=1500 ➔ 5000 | Trial completion date: Mar 2022 ➔ Oct 2024 | Trial primary completion date: Dec 2021 ➔ Jul 2023

Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

PREVENT: Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19 (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: UNION therapeutics | N=330 ➔ 4 | Recruiting ➔ Terminated; Failure of recruiting patients

Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease

PREVENT: Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19 (clinicaltrials.gov) - P2; N=330; Recruiting; Sponsor: UNION therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

PREVENT: Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19 (clinicaltrials.gov) - P2; N=330; Not yet recruiting; Sponsor: UNION therapeutics

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Study to test UNI91103 in adults with Covid-19 and no or only mild symptoms (clinicaltrialsregister.eu) - P2; N=330; Ongoing; Sponsor: UNION therapeutics A/S

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

UNION therapeutics' COVID-19 candidates found to be well tolerated in Phase 1 Lancet publication 10 (PRNewswire) - P1, N=44; "With no serious adverse effects reported, the study showed a strong safety profile of inhaled and intranasal niclosamide which was the primary endpoint for the trial. The promising safety and pharmacokinetic results for inhaled and intranasal niclosamide have opened the doors for further investigation, and will now be tested as a potential treatment (UNI91104) and prophylaxis (UNI91103) for COVID-19....The phase 1 trial described in the publication was randomized, placebo-controlled, double-blinded, multi-ascending dose...The phase 1 trial met all its endpoints and demonstrated that the concentrated niclosamide solution of UNION therapeutics is well tolerated when administered via the intranasal and inhaled route. The study results demonstrated a dose-proportional pharmacokinetic and showed no signs of systemic accumulation of the drug in the blood."

P1 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease

The PROTECT-V trial investigating UNIONs COVID-19 candidate receives Urgent Public Health Prioritization from the UK government (PRNewswire) - "UNION therapeutics A/S (UNION) today announced that the National Institute for Health Research (NIHR) in the UK has granted Urgent Public Health (UPH) prioritization to the PROTECT-V trial - a platform study investigating UNION's niclosamide-based treatment candidate for COVID-19 in kidney patients....UPH prioritization will enable streamlined site set up across the UK, and facilitate rapid patient recruitment..."

Trial status • Infectious Disease • Novel Coronavirus Disease

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

Enrollment status • Infectious Disease • Novel Coronavirus Disease

Danish biotech UNION adds program to prevent COVID-19 with intranasal delivery of niclosamide (PRNewswire) - P1, N=44; "UNI91103 is a nasal spray pump delivering a concentrated niclosamide salt solution to the nasal cavity; UNION therapeutics A/S (UNION) announces expansion of the clinical pipeline with the addition of UNI91103....UNI91103 will first be investigated in high risk patients to test its ability....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....UNION therapeutics expects to commence patient trials using UNI91103 in Q4 2020."

General devices event • New trial • P1 data • Infectious Disease • Novel Coronavirus Disease