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Ingelheim (ots) – The study examines the new first-in-class active ingredient BI 764198 in hospital patients with SARS-CoV-2 infection and severe respiratory complications for whom only very limited medical treatment options are currently available. – The new treatment option could benefit 67 to 85 percent of COVID-19 ICU patients with acute respiratory distress syndrome, 1 which could reduce the need for artificial ventilation and save lives. – The initiation of this Phase 2 trial is part of Boehringer Ingelheim’s efforts to accelerate the discovery and development of much-needed drugs for COVID-19 patients.
Boehringer Ingelheim today announced the start of a phase 2 clinical trial of BI 764198, a potential cation channel receptor 6 (TRPC6) inhibitor. The active ingredient is a potential targeted therapy to reduce the risk or severity of acute respiratory complications in hospital patients with COVID-19. The purpose of treatment with BI 764198 is to reduce the need for artificial ventilation, improve the patient’s recovery rate and save lives. Boehringer Ingelheim is committed to the fight against COVID-19, using its know-how and resources to develop new treatment options for patients suffering from severe complications caused by the SARS-CoV-2 virus.
“COVID-19 can lead to severe lung problems such as pneumonia in patients and, in severe cases, to acute respiratory distress syndrome (ARDS) or even lung failure,” said Dr. Lorraine B. Ware, chair of Ralph and Lulu Owen Endowed and Professor of Medicine, Pathology, Microbiology and Immunology at Vanderbilt University, Tennessee (USA). “Patients in hospital with COVID-19-associated acute respiratory distress syndrome are often unable to breathe on their own and may need ventilators to keep their bodies adequately oxygenated. We hope, of course, that future vaccines will bring them. one Will help reduce the number of cases of COVID-19 patients with severe disease, however, it is important to address unmet needs in addressing respiratory complications in patients and offer healthcare professionals an effective alternative to ventilators, which can reduce the burden of treatment in hospitals can reduce. “
About 15% of all SARS-CoV-2 patients exhibit a severe disease course and up to 30% of seriously ill patients potentially require intensive care. Acute respiratory distress syndrome, a potentially fatal complication of severe COVID-19 disease, develops in 67-85% of patients in intensive care units. 1 Treatment options such as BI 764198 are urgently needed to reduce severe shortness of breath, save lives, and last but not least, mitigate the virus’s drastic effects on healthcare systems.
“This therapy could represent the first potential treatment option for COVID-19 respiratory distress syndrome and help fill a large gap in the treatment regimen for COVID-19 patients. We have carefully analyzed the pathology of COVID-19 during this year and with BI 764198 we have found a potential new approach to alleviate the severe course of the disease and we consider it our duty to test this new approach in the clinic “, explains Dr. Mehdi Shahidi, Corporate Senior Vice President Medicine and Chief Medical Officer at Boehringer Ingelheim. “We hope this is an important step forward and offers treating physicians a new tool that will improve the outlook for their COVID-19 patients with respiratory complications in hospitals.”
As a research-driven company, Boehringer Ingelheim is part of the global effort to combat COVID-19. The company has initiated a range of activities in its fields of expertise to find solutions to the pandemic and is working closely with academic research experts, international institutions and other players in the pharmaceutical industry. Boehringer Ingelheim is currently involved in a wide range of initiatives aimed at fighting the disease and saving the lives of patients. This includes the research and development of SARS-CoV-2 antibodies, which can neutralize the virus, and small molecules to inhibit its reproduction, as well as the development of a treatment to prevent microcoagulation (blood clots). Boehringer Ingelheim also actively supports the Bill and Melinda Gates Foundation’s initiative to ensure equal global access to therapies and vaccines, as well as global development initiatives such as the COVID-19 Therapeutics Accelerator (CTA) and Covid Accelerate Research in Europe (CARE ) Consortium.
I study
The Phase 2, randomized, double-blind, placebo-controlled clinical trial is evaluating BI 764198 in patients hospitalized for COVID-19. As part of the study, test subjects will be given one capsule per day for up to four weeks. The primary endpoint is the percentage of patients who are alive on day 29 of treatment and do not require artificial ventilation. Other endpoints are improvement in clinical symptoms, oxygen saturation and the need to be transferred to the intensive care unit. In hospital-treated COVID-19 patients, there is an increase in reactive oxygen species (ROS) due to damage to the airways. ROS has been shown to activate TRPC6, which can lead to a range of cellular damage, which in turn can lead to disruption of cell barrier function, hyperpermeability, edema, and ultimately acute respiratory distress syndrome (ARDS ). Treatment with BI 764198 for lung injury in an animal model demonstrated a reduction in lung damage and pulmonary edema. Treatment with BI 764198 could provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 was well tolerated in a Phase 1 study in healthy adults (NCT03854552).
Recruitment for the study for BI 764198 will begin in October 2020 and the study will be conducted at approximately 40 study locations in eight countries.
Further information is available at:
https://ots.de/FjrEDb and https://www.mystudywindow.com/trial/listing/257155
Credentials:
1 Centers for Disease Control and Prevention (CDC). “Interim Clinical Guidelines for the Management of Patients with Confirmed Coronavirus Disease (COVID-19).” Abgerufen auf: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-m anagement-patient.html. Abgerufen am 19. April 2020.
Boehringer Ingelheim
Developing new and better drugs for humans and animals is what we do. Our mission is to develop innovative, life-changing therapies. Boehringer Ingelheim has been an independent, family-owned company since its founding in 1885. This leaves us free to pursue our long-term vision: identify the health challenges of the future and act where we can achieve the most.
At our world-leading, research-driven company, over 51,000 employees create value every day through innovation in our three business areas: human pharmaceuticals, animal health and contract biopharmaceutical manufacturing. In 2019, Boehringer Ingelheim achieved a turnover of 19 billion euros. Our massive investments of just under € 3.5 billion in research and development act as engines of innovation and enable the next generation of medicines that save lives and improve the quality of life.
We can exploit more scientific opportunities by relying on the power of partnerships and the diversity of experts in the life sciences. By working together, we can more quickly achieve the next medical breakthrough that will transform patients’ lives today and tomorrow.
Further information on Boehringer Ingelheim can be found at http://www.boehringer-ingelheim.de and in our company report: http://unternehmensbericht.boehringer-ingelheim.de/.
Press contact:
Boehringer Ingelheim Corporate Communications Matthias Reinig 55216 Ingelheim Telephone: 06132-77 184855 E-Mail: mailto: [email protected]
Other material: http://presseportal.de/pm/6631/4747306 OTS: Boehringer Ingelheim
Original content by: Boehringer Ingelheim, broadcast by news aktuell
Presseportal-Editorial: Boehringer Ingelheim
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