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Boehringer Ingelheim Begins Phase 2 Clinical Trial of a Targeted Therapy to Help People with Severe Respiratory Illness from COVID-19
Boehringer Ingelheim today announced the initiation of a Phase 2 clinical trial of BI 764198, an inhibitor of TRPC6, a receptor-operated cation channel. This potent and selective inhibitor of TRPC6 may alleviate the damage to the lung and decrease the risk or severity of acute respiratory complications in patients hospitalized for COVID-19. The aim of therapy with BI 764198 is to reduce the need for ventilator support, to improve patient recovery rate and ultimately to save lives. Boehringer Ingelheim is committed to fighting COVID-19 and contributing with its expertise and resources to develop new therapeutic options for patients suffering from the virus' severe complications.
"COVID-19 can cause serious lung complications, such as viral pneumonia, and in severe cases can lead to acute respiratory distress syndrome (ARDS) and lung failure," said Dr. Lorraine B. Ware, Ralph and Lulu Oven Endowed Chair and Professor of Medicine, and Pathology, Microbiology and Immunology, Vanderbilt University. "Patients hospitalized with ARDS due to COVID-19 are often unable to breathe on their own and may require life support from a mechanical ventilator to help supply oxygen to the body. While we hope that future vaccines will help reduce cases of severe COVID-19, there remains an unmet need to address respiratory complications in infected patients, and provide healthcare professionals an effective alternative to mechanical ventilation that can potentially reduce the treatment burden within the hospital setting."
Approximately 15% of patients infected with SARS-CoV-2 develop severe disease and up to 30% of severely ill patients may require medical care in an intensive care unit (ICU). Between 67 and 85 percent of patients in the ICU develop ARDS, a potentially deadly complication of severe COVID-19.1 Therapeutic options, such as BI 764198, are urgently needed to reduce severe respiratory distress, save lives and ultimately help reduce the incredible burden the virus is placing on healthcare systems.
"This therapy may provide the first potential treatment for COVID-19 related respiratory distress syndrome, helping to close a significant gap in the treatment regimen for COVID-19 patients. As we have understood more in recent months about the pathology of this disease, we realized that BI 764198 might have a unique potential to help the most severely affected patients and we felt compelled to bring it to clinical studies," said Dr. Mehdi Shahidi, Corporate Senior Vice President Medicine and Chief Medical Officer, Boehringer Ingelheim. "It is our hope that this step forward will provide treating physicians with a new tool to improve the outlook for their hospitalized patients affected by the respiratory complications of COVID-19."
As a research-driven company, Boehringer Ingelheim is part of the collective effort in fighting COVID-19. Drawing from their areas of expertise, the company has engaged in a number of activities to find medical solutions to this pandemic, working closely with academic researchers, international institutions, and others in the pharma industry. Boehringer Ingelheim is currently involved in a broad set of initiatives to fight the disease and save patients' lives, including the research and development of SARS-CoV-2 antibodies that can neutralize the virus, small molecules to inhibit its replication, and therapy development to prevent microcoagulation (blood clots). Boehringer Ingelheim is also an active participant in the global access initiative with the Bill and Melinda Gates Foundation as well as global development initiatives including the COVID-19 Therapeutics Accelerator (CTA) and the CARE Consortium.
About the Study
This Phase 2 randomized double-blind placebo-controlled trial will evaluate BI 764198 in patients hospitalized for COVID-19 with participants taking one capsule per day for up to four weeks. The primary endpoint will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment. Other endpoints include clinical improvement, oxygen saturation and ICU admission. In patients hospitalized for COVID-19, there is an increase in reactive oxygen species (ROS) due to airway injury. ROS have been shown to activate TRPC6, which may cause a cascade of cellular damage resulting in disruption of cellular barrier function, hyper-permeability, edema and ultimately acute respiratory distress syndrome (ARDS). BI 764198 treatment in animal models of lung injury has been shown to reduce cellular damage and lung edema. Treatment with BI 764198 may provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 has been shown to be well tolerated in a previous Phase 1 study in healthy adults (NCT03854552).
Trial enrollment for BI 764198 is expected to begin in October 2020 and will include approximately 40 study sites across eight countries. For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT04604184?cond=covid&spons=Boehringer&draw=2&rank=1 and https://www.mystudywindow.com/?global=1
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