. Phase II study assessing BI 764198, a novel first-in-class compound, for patients hospitalized with COVID-19 with respiratory complications discontinued due to lack of efficacy in this indication.
• Boehringer Ingelheim remains committed to other research and development efforts in COVID-19 including new SARS-CoV-2 neutralizing antibodies.

Ingelheim, Germany, [12 March 2021] Boehringer Ingelheim today announced that it has decided to discontinue treatment in the Phase II trial of a novel, first-in-class compound for reducing the risk or severity of acute respiratory distress syndrome (ARDS) in patients hospitalized for COVID-19 and requiring non-invasive oxygen support.

This decision is based on the recommendation of the trial’s independent Data Monitoring Committee after an interim look at unblinded safety and efficacy data showing a clear lack of benefit for use of BI 764198 in patients hospitalized for COVID-19 and needing oxygen support.

“The discontinuation of this Phase II trial underscores how challenging it is to develop treatments to help patients with COVID-19-induced ARDS. We believe that beyond vaccines, effective treatments for COVID-19 and its complications are urgently needed and we will continue other trial programs including the research and development of a SARS-CoV-2 neutralizing antibody that can be administered via inhalation,” said Dr. Mehdi Shahidi, Corporate Senior Vice President Medicine and Chief Medical Officer, Boehringer Ingelheim. “We are grateful to the participating patients and highly appreciate the unwavering commitment and outstanding support of our partners and colleagues that enabled the clinical study on the shortest possible timelines.”

Boehringer Ingelheim remains involved in various initiatives to fight COVID-19, leveraging the company’s expertise in antibody development and production, vascular and respiratory disease, combined with a focus on patient-centric innovation. This includes the research and development of COVID-19 antibodies that can neutralize the virus and the development of therapies to prevent blood clots.

A final assessment of the efficacy and safety of the compound will be published in the coming months, following review of the full trial data set.

For further information visit: www.boehringer-ingelheim.com/covid-19/fighting-covid-19