Boehringer Ingelheim, Cologne University Hospital (UKK), University of Marburg (UMR) and the German Center for Infection Research (DZIF) have initiated Phase I/IIa clinical investigation of novel SARS-CoV-2 neutralising antibody, BI 767551.

A potent anti-SARS-CoV-2 antibody, BI 767551 (DZIF-10c) has demonstrated promising virus neutralising properties in pre-clinical studies.

Merging UKK, UMR and DZIF’s expertise in virology, immunology and clinical investigation with Boehringer Ingelheim’s capabilities in developing and manufacturing therapeutic antibodies, BI 767551 was developed as a potential new therapeutic and preventive/prophylactic option for Covid-19.

To be led by UKK professors Florian Klein and Gerd Fätkenheuer, the study will be supplied with the antibody by Boehringer Ingelheim.

The Phase I/IIa studies will analyse the safety, pharmacokinetics and antiviral activity of the antibody. The first patients for the study have been enrolled.

In Phase I part of the study, participants will be given a single infusion or a single inhalation of the antibody.

Late-stage confirmatory studies will be conducted if BI 767551 is observed to be well tolerated.

Boehringer Ingelheim Innovation Unit Board of Managing Directors member Michel Pairet said: “We are excited to contribute to the development of BI 767551 in collaboration with our partners, with the aim to provide an innovative SARS-CoV-2 neutralising antibody, combining a systemic with an inhaled route of administration.”

University of Marburg Institute of Virology Director and DZIF Emerging Infections coordinator Prof Stephan Becker said: “Monoclonal antibodies are a promising component in the fight against new viruses, such as the SARS-CoV-2.

“If this antibody turns out to be effective against COVID-19, this finding could be helpful in the current and also in future epidemics and pandemics.”

Last month, the Icahn School of Medicine at Mount Sinai, Department of Medicine’s Clinical Trials Office and Boehringer Ingelheim enrolled the first patient to evaluate nintedanib in adult patients with acute lung injury following Covid-19 infection.