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
Please click on the link for ‘Notes to Editors’ and ‘References’:
Dr. Reinhard Malin
Head of Communications Innovation Unit
Boehringer Ingelheim Corporate Center GmbH
Media + PR
P: +49 6132 77-90815
Senior Associate Director, Media and Corporate Reputation
Boehringer Ingelheim U.S.
Media + PR
P: +1 203-791-6672
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Vertex Announces European Commission Approval for SYMKEVI® (tezacaftor/ivacaftor) With KALYDECO® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years27.11.2020 11:00:00 EET | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval of the label extension for SYMKEVI® (tezacaftor/ivacaftor) with KALYDECO® (ivacaftor), to include the treatment of cystic fibrosis (CF) in patients ages 6 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or one copy of the F508del mutation and one copy of one of 14 mutations in the CFTR gene that result in residual CFTR activity: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T. “With this approval, children with CF in Europe ages 6 to 11 years with the most common mutation, F508del, have a new treatment option and children with certain residual function mutations will, for the first time, have a treatment option available that addresses the underlying cause of their CF,” said Reshma Kewalramani, M.D., Chief Executive O
REPLY: Reply enters into eSports27.11.2020 11:00:00 EET | Press release
Reply, on the eve of Milan Games Week, announces its entry into eSports in collaboration with Totem eSports, a project born in 2019 that spent the year battling its way through the most competitive titles of the main ESL circuits, which for the 2021 season will be renamed Reply Totem eSports. The Reply Totem eSports team, thanks to the experience gained by its young talents at national and international level, will compete in the next season in the ESL EVC circuits on the mobile titles including Clash Royale, Brawl Stars and on a series of other titles, ranging from sports such as FIFA to FPS and strategic cards. Reply's entry into eSports is part of a wider range of initiatives aimed at supporting young technology enthusiasts. With this collaboration, Reply, which already operates in the gaming sector with Game Studio and B2B initiatives, enters a market in continuous growth, that symbolizes the impact of digitalization in all sectors. Filippo Rizzante, Reply's CTO, commented: "The eS
Thales to Deliver the World’s First Fully Integrated Unmanned Mine Countermeasures System for the Royal Navy and French “Marine Nationale”26.11.2020 22:55:00 EET | Press release
Following the first phase of the program in which two demonstrators have successfully proven their operational performances at sea, France and the United Kingdom marked the tenth anniversary of the Lancaster House treaties by signing a joint contract for Thales to start the production phase of MMCM to deliver eight unmanned mine hunting systems (four for France and four for the United Kingdom). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005783/en/ MMCM system at sea ©Thales With the threat of mines and improvised explosive devices present in all conflicts involving naval forces, countries need to strengthen the protection of their maritime domain, to ensure the protection of their assets and to safeguard the freedom of civil navigation. At the same time, it is essential to limit human exposure to mines. With 50 years of expertise serving navies around the world, Thales develops technologies that enable the transiti
Saudi Urban20 Chair Wishes Italy ‘Buona Fortuna’ With the 2021 Urban20 Presidency26.11.2020 16:47:00 EET | Press release
The Urban20 (U20) Chair, His Excellency Fahd Al-Rasheed, President of the Royal Commission for Riyadh City has today wished his Italian counterparts good luck or “Buona Fortuna” as Italy prepares to take up the reins of the 2021 G20 Presidency and the engagement group of cities, the U20. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005650/en/ HE Fahd Al-Rasheed, chair of U20 Riyadh 2020 - (Photo - AETOSWire) “The city of Riyadh is immensely proud and honored to have Chaired the 2020 U20. We are proud of the progress we made together as the U20 of 42 cities and 30 think tanks, universities, and multi-lateral entities. We collaborated, innovated and found common ground. We discussed challenges and solutions experienced by cities across every continent. We focused on the common goal of rebuilding better. As we worked to bring urban issues to the fore, a record 39 mayors and representatives of leading cities endorsed the
DEWA Innovation Centre and 800MW 3rd Phase of the Mohammed bin Rashid Al Maktoum Solar Park Inaugurated26.11.2020 16:31:00 EET | Press release
HH Sheikh Mohammed bin Rashid Al Maktoum, Vice President and Prime Minister of the UAE and Ruler of Dubai, has inaugurated Dubai Electricity and Water Authority’s (DEWA’s) Innovation Centre and the 800MW third phase of the Mohammed bin Rashid Al Maktoum Solar Park, the largest single-site solar park in the world. The solar park has a planned capacity of 5,000MW by 2030, with investments up to AED50 billion. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005645/en/ DEWA Innovation Centre and 800MW 3rd phase of the Mohammed bin Rashid Al Maktoum Solar Park inaugurated (Photo: AETOSWire) HH Sheikh Mohammed bin Rashid Al Maktoum was briefed by HE Saeed Mohammed Al Tayer, MD & CEO of DEWA, about the Innovation Centre, which is a global hub for renewable and clean energy innovation. It supports innovation and creativity in clean and renewable energy, promotes sustainability, develops Emirati talent and enhances the UAE’s com
Leveraging Its Mobile ID, IDEMIA Brings Digital Travel Credentials to Life26.11.2020 16:30:00 EET | Press release
Digital Travel Credentials make traveling between airports and airlines a more enjoyable experience and bolsters passenger trust in airport services and systems. On 10-11 November 2020, at the ICAO virtual conference, IDEMIA demonstrated with an airline partner its breakthrough innovation capabilities to present a fully operational solution, bringing DTC to life. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005534/en/ (Photo: Buiness Wire) Leveraging its Mobile ID solution and passenger flow facilitation solutions, IDEMIA simulated a passenger DTC for check in and smart boarding. Passengers can speed through all airport touchpoints thanks to fast and ultra-secure biometric identification. IDEMIA’s DTC treat private data with the same security level as for paper passports. “This DTC demonstrator illustrates the innovative capabilities of IDEMIA to perform a highly secure, reliable and smooth identity verification of t
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom