DZIF-10c inhalation / Boehringer Ingelheim - LARVOL DELTA

Semi-mechanistic population pharmacokinetic modeling of DZIF-10c, a neutralizing antibody against SARS-Cov-2: predicting systemic and lung exposure following inhaled and intravenous administration. (PubMed, J Pharmacokinet Pharmacodyn) - "Combining inhalation with intravenous therapy results in high and sustained DZIF-10c exposure in the lungs and systemic circulation, thereby combining the benefits of both routes of administration. By combining preclinical data with clinical data (via allometric scaling principles), the developed population pharmacokinetic model reduced uncertainty around exposure in the lungs allowing evaluation of alternative dosing strategies to achieve the desired concentrations of DZIF-10c in human lungs."

Journal • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Uni-Koeln-4370: SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation (clinicaltrials.gov) - P1/2 | N=45 | Terminated | Sponsor: University of Cologne | Completed ➔ Terminated; Change in viral variant epidemiology

Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (clinicaltrials.gov) - P2/3; N=5; Terminated; Sponsor: Boehringer Ingelheim; Active, not recruiting ➔ Terminated; not due to safety reasons

Clinical • Trial termination • Infectious Disease • Novel Coronavirus Disease • PCR

Uni-Koeln-4370: SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation (clinicaltrials.gov) - P1/2; N=45; Completed; Sponsor: University of Cologne; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (clinicaltrials.gov) - P2/3; N=5; Active, not recruiting; Sponsor: Boehringer Ingelheim; N=1500 ➔ 5

Clinical • Enrollment change • Infectious Disease • Novel Coronavirus Disease • PCR

A Study to Test Whether BI 767551 Can Prevent COVID-19 in People Who Have Been Exposed to SARS-CoV-2 (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: Boehringer Ingelheim; N=1700 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Uni-Koeln-4370: SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation (clinicaltrials.gov) - P1/2; N=45; Active, not recruiting; Sponsor: University of Cologne; Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (clinicaltrials.gov) - P2/3; N=5; Active, not recruiting; Sponsor: Boehringer Ingelheim; Terminated ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • PCR

Boehringer takes alteplase to phase 3 for COVID, but drops antibody (pharmaphorum) - "Boehringer Ingelheim’s latecomer antibody therapy for COVID-19 has been side-lined, as the company focuses its attention on its thrombolytic drug alteplase, heading into a phase 3 programme later this year. The decision to discontinue development of BI 767551, an inhaled antibody, has been taken because of the 'evolving landscape' in managing the pandemic...That leaves Actilyse (alteplase) as the last COVID-19 project standing at the German drugmaker, but here there is good news with 'favourable' safety and efficacy data from an interim analysis of the phase 2b portion of its TRISTARDS study in 62 patients. Results from the study are expected next year."

Discontinued • P2/3 data • Trial status • Infectious Disease • Novel Coronavirus Disease

A study to test whether BI 767551 can prevent COVID-19 in people who might have been exposed to SARS-CoV-2 (clinicaltrialsregister.eu) - P3; N=1700; Ongoing; Sponsor: SCS Boehringer Ingelheim Comm. V

Clinical • New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (clinicaltrials.gov) - P2/3; N=1500; Recruiting; Sponsor: Boehringer Ingelheim; Trial primary completion date: May 2021 ➔ May 2022

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

A Study to Test Whether BI 767551 Can Prevent COVID-19 in People Who Have Been Exposed to SARS-CoV-2 (clinicaltrials.gov) - P3; N=1700; Not yet recruiting; Sponsor: Boehringer Ingelheim

Clinical • New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (clinicaltrials.gov) - P2/3; N=1440; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (clinicaltrials.gov) - P2/3; N=1440; Not yet recruiting; Sponsor: Boehringer Ingelheim

New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • PCR

SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation (clinicaltrials.gov) - P1/2; N=78; Recruiting; Sponsor: University of Cologne; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Trial to test the safety, half-life, and antiviral efficacy of a new drug (human antibody) called DZIF-10c (administered inhalatively) in healthy volunteers and SARS-CoV-2-infected participants Studie zur Bewertung der Sicherheit, Halbwertszeit und antiviralen Wirksamkeit eines neuen Medikamentes (humaner Antikörper) namens DZIF-10c (inhalativ verabreicht) mit gesunden Personen und mit... (clinicaltrialsregister.eu) - P1/2; N=96; Ongoing; Sponsor: University of Cologne

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

New SARS-CoV-2 Neutralizing Antibody enters Clinical Phase (Businesswire) - "Cologne University Hospital (UKK), University of Marburg (UMR), the German Center for Infection Research (DZIF) and Boehringer Ingelheim today announced the initiation of Phase 1/2a clinical investigation of BI 767551...They are being investigated as a therapy option for individuals with mild or severe infections, but also as prevention or prophylaxis in non-infected people...In Phase 1, the antibody will be administered to participants either with a single infusion or a single inhalation."

Trial status • Infectious Disease • Novel Coronavirus Disease

COVID-19 - Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c (Inhalation) (clinicaltrials.gov) - P1/2; N=69; Not yet recruiting; Sponsor: University of Cologne

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases