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’:
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
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
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
Dare to DeFi: DeFi Summit’s First-Ever Global Virtual Conference Brings Together Over 120 Top Industry Leaders14.6.2021 02:15:00 CEST | Press release
The largest-ever dedicated conference focused specifically on decentralized finance starts today at 9am Pacific Time. DeFi Summit is a weeklong virtual event bringing together the builders and developers that make up the decentralized finance and non-fungible token community. Free to attend, talks and presentations will be held on a broad range of topics, including DEX, wallets, DAOs, NFTs, insurance, lending, and many more. DeFi Summit 2021 Agenda: Day 1 (Monday, June 14) – The summit starts with a full day focused on NFTs. Notable speakers include digital artists Pplpleasr and Matty Mo, Max Moore of Sotheby’s, and companies including Axie Infinity, Animoca Brands and Aavegotchi. Day 2 (Tuesday, June 15) – A mystery billionaire investor is the special guestjoining Polygon Power Hour alongside Stani Kulechov from Aave, Sandeep Naiwal from Polygon and Roc Zacharias from Quickswap. Stay tuned for Coinbase, Unicrypt, Finance.Vote, and YFDAI, plus an exciting panel featuring OG DeFi VCs Le
Celltrion Healthcare presents the first real-world data for Truxima ® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress12.6.2021 17:45:00 CEST | Press release
Celltrion Healthcare today presented new data from its post-approval study evaluating the real-world clinical effectiveness and safety of Truxima® (biosimilar rituximab, CT-P10) in patients with diffuse large B-cell lymphoma (DLBCL) at the European Hematology Association (EHA) 2021 Virtual Congress.1 CT-P10 was granted European Medicines Agency approval in 2017 for the treatment of rheumatoid arthritis (RA) and specific blood cancers, including non-Hodgkin’s lymphoma (NHL).2 DLBCL is the most common subtype of NHL, representing an estimated 30-40% of adult cases.3,4,5,6 This non-interventional post-authorisation safety study (PASS) involved the collection of patient-level data from hospital medical records for patients with DLBCL who received CT-P10 treatment in five European countries (United Kingdom, Spain, France, Germany and Italy). CT-P10 treatment pattern data were collected retrospectively during the 30-month observation period and patients were selected based on the treatment t
Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX ® ▼ (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible12.6.2021 09:01:00 CEST | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 MAIA (NCT02252172) study showing the addition of DARZALEX® ▼(daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression.1 These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefing and will be presented as a late-breaking abstract during the EHA Virtual Congress (Abstract #LB1901). The prespecified interim analysis for OS found that after a median follow-up of nearly five years (56.2 months), a 32 percent reduction in the risk of death was observed in the D-Rd treatment arm vs. Rd arm.1 Median OS was not reached in either arm [hazard ratio (HR): 0.68, 95 percent confidence interval (CI),
New Phase 3 Study Results Show IMBRUVICA ® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia12.6.2021 09:00:00 CEST | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced primary results from the pivotal Phase 3 GLOW study (NCT03462719) evaluating fixed-duration IMBRUVICA® (ibrutinib) plus venetoclax (I+V) compared to chlorambucil plus obinutuzumab (Clb+O) for first-line treatment of elderly or unfit patients with chronic lymphocytic leukaemia (CLL). The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duration of remission and significantly improved depth of remission.1 With I+V, undetectable minimal residual disease (uMRD) in peripheral blood (PB) was sustained by 85 percent of patients one year after end of treatment.1 The safety and tolerability profile of I+V was consistent with CLL treatment in an older population with comorbidities.1 These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefing an
Alluzience ® , the first ready-to-use BoNT-A neuromodulator, receives positive decision for use in Europe11.6.2021 11:53:00 CEST | Press release
Galderma today announced that Alluzience® has completed its European decentralized procedure resulting in a positive decision for the first ready-to-use neuromodulator, a wrinkle relaxing injection, in Europe. National approvals will now take place across the region in line with local processes in each country. Designed for precision, Alluzience® is a liquid form of botulinum toxin type A intended for use in adult patients as a treatment to temporarily improve the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows), when the severity of these lines has an important psychological impact on the patient.1 "The introduction of Alluzience® marks a new era in treatment innovation for upper facial lines in Europe. Like many aspects of physical appearance, glabellar lines can have a significant impact on patients’ confidence and wellbeing. I’ve heard first-hand that the transition to living and working in a virtual world has only exacerbated these issues. As
Secure Communities Forum: Behavioural Insights Can Assist Governments in the Post-Pandemic World11.6.2021 10:15:00 CEST | Press release
The Secure Communities Forum, a global collaboration of security professionals, has convened a leading panel of experts to discuss how behavioural science can impact positive social cohesion, build on the concept of positive citizenship, and encourage positive individual behaviours. The virtual event was attended by 134 people from 18 countries. The Secure Communities Forum convened the webinar in response to the ongoing Covid-19 pandemic. Governments and law enforcement agencies have used behavioural science to encourage adherence to public health measures like social distancing and mask-wearing. Lindsay Juarez, Director at Irrational Labs, USA, opened the session, offering the view that we assume humans are rational, which is not the case. She said: “Behavioural science is about setting people up for success and breaking through the noise. Information isn't enough to change behaviour, the decision-making context matters. “People don’t always act in their own long-term best interests,
Luxembourg’s Supercomputer MeluXina is Operational11.6.2021 09:18:00 CEST | Press release
Luxembourg’s high performance computer MeluXina was officially launched on June 7 putting the country on the global map of computer super powers. MeluXina is capable of executing more than 10 Petaflops, the equivalent of 10 million billion calculations per second, which will rank it among the world’s top 50 supercomputers. The petascale computer is powered by green energy and is part-funded under the European High Performance Computing Joint Undertaking. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210611005115/en/ Minister of State Xavier Bettel; His Royal Highness Henri, Grand Duke of Luxembourg; Minister of the Economy Franz Fayot; EuroHPC Joint Undertaking Executive Director Anders Jensen (Photo: Business Wire) In a series of 8 high-performance computers in the EU, MeluXina joins Vega, another petascale supercomputer located in Slovenia, as the first EuroHPC machines to go live. Its innovative modular architecture allo
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