niclosamide inhalation (UNI91104) / UNION Therap, Institut Pasteur Korea - LARVOL DELTA

Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults With COVID-19 (clinicaltrials.gov) - P1; N=64; Completed; Sponsor: UNION therapeutics; Active, not recruiting ➔ Completed; Trial completion date: Apr 2021 ➔ Dec 2020

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease

A randomized, double-blind, placebo-controlled phase 1 trial of inhaled and intranasal niclosamide: A broad spectrum antiviral candidate for treatment of COVID-19. (PubMed, Lancet Reg Health Eur) - P1 | "Coronavirus disease 19 (COVID-19) is spreading globally and treatment options remain limited. UNI91104, a promising candidate for inhalation and intranasal therapy against COVID-19 and other viral respiratory tract infections is well-tolerated in healthy volunteers and warrants further testing in patient trials. The study was funded by Innovationsfonden Denmark and UNION therapeutics."

Clinical • Journal • P1 data • Allergy • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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

Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults With COVID-19 (clinicaltrials.gov) - P1; N=64; Active, not recruiting; Sponsor: UNION therapeutics; Recruiting ➔ Active, not recruiting; N=44 ➔ 64; Trial completion date: Dec 2020 ➔ Apr 2021

Clinical • Enrollment change • Enrollment closed • Trial completion date • 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

Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults With COVID-19 (clinicaltrials.gov) - P1; N=44; Recruiting; Sponsor: UNION therapeutics

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease

UNION therapeutics A/S completes dosing of healthy volunteers with UNI911 (inhaled niclosamide) for COVID-19 (PRNewswire) - P1, N=44; "UNION therapeutics...today announces the successful completion of dosing of 44 healthy volunteers with UNI911....The study was a double-blind, placebo-controlled, randomized study, where ascending single and multiple dosing regimens were given to 44 healthy volunteers by inhalation across five cohorts....The Safety Monitoring Committee assessed the safety of UNI911 in each cohort before dose escalation in the next cohort was initiated...'The study confirmed that the drug is safe when administered by inhalation'..."

DSMB • P1 data • Trial status • Infectious Disease • Novel Coronavirus Disease

UNION therapeutics A/S enters option agreement to acquire worldwide exclusive license for COVID-19 technologies developed by TFF Pharmaceuticals, Inc. (PRNewswire) - "UNION therapeutics A/S ('UNION') today announced the completion of an agreement with TFF Pharmaceuticals, Inc. ('TFF') to acquire an option to obtain a worldwide exclusive license for...niclosamide to focus on treatments for COVID-19....UNION will acquire an option to obtain a worldwide exclusive license to the technology and rights relating to the formulations of niclosamide for the treatment of COVID-19....UNION will pay TFF up to 210 million USD related to option exercise, development and commercial milestones, as well as tiered single-digit royalties on product sales."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

UNION Receives Approval From Danish Medicines Agency to Initiate Clinical Study With Niclosamide for Treatment of COVID-19 (PRNewswire) - "UNION therapeutics...announced this morning that the Danish Medicines Agency has approved initiation of a clinical study with an optimized salt form of niclosamide as a new treatment candidate for COVID-19....UNION is conducting the first human study at the Zelo Phase I Unit at Bispebjerg and Frederiksberg Hopsital as well as Center for Physical Activity Research at Rigshospitalet, in collaboration with Trial Nation Denmark and the Technical University of Denmark, and with financial support from the Innovation Fund Denmark."

European regulatory • Financing • New P1 trial • Infectious Disease • Novel Coronavirus Disease