Foundation for Sarcoidosis Research
  • About Us
  • News
  • Blog
  • Support Groups
  • Facebook
  • Twitter
  • YouTube
  • Instagram
Menu
  • About FSR
    • Who We Are
      • Our History
      • Our Board of Directors
      • Our Scientific Advisory Board
      • Our Staff
    • What We Do
      • Our Mission
      • Our Approach
      • Affiliations
      • Financials
    • Close
  • Understanding Sarcoidosis
    • What is Sarcoidosis?
      • Symptoms
      • Diagnosis
      • Organs Involved
      • Causes and Risk Factors
    • Treatment Options
      • Overview
      • Physician’s Treatment Protocol
      • Side Effects
      • Complications and Comorbidities
    • Close
  • Living with Sarcoidosis
    • Get Involved
      • Donate
      • Volunteer
      • Join Registry
      • Team KISS
    • Find Information
      • Find a Physician
      • Find a Clinical Trial
      • Video Library
      • Educational Resources
    • Find Support
      • Support Groups
      • Patient Navigators
      • Patient Summits
    • Lifestyle
      • Wellness and Self-Care
      • Diet
      • Exercise
    • Close
  • Medical Community
    • Healthcare Providers
      • Treatment Protocol and Guidelines
      • FSR-WASOG Recognized Clinics
      • FSR Fellowship Program
      • Join Our Physician Community
    • Investigators
      • Our Research Approach
      • Current Funding Opportunities
      • SARConnect
    • FSR Research Programs
      • Clinical Studies Network
      • Sarcoidosis Model
      • Springboard Grant Program
    • Close
  • Investors
      • Make a Donation
      • Our Impact
      • Our Funders
    • Close
Select Page
  • Donate Now
  • Take Action
    • Ways to Give
    • Join Team KISS
    • Start a Fundraiser
    • Find an Event
    • FSR Advocacy Program
    • Participate in a Clinical Trial
    • Share Your Story

Boehringer Ingelheim Therapy for COVID-19 Advances to Phase 2

Oct 29, 2020 | Community Partners, News | 0 comments

The following is an exciting announcement from an FSR partner, Boehringer Ingelheim – see the release on their website here.

Boehringer Ingelheim Begins Phase 2 Clinical Trial of a Targeted Therapy to Help People with Severe Respiratory Illness from COVID-19

  • Trial will evaluate BI 764198, a novel first-in-class compound, for hospitalized people infected with SARS-CoV-2 with severe respiratory complications for which very limited treatment options are currently available.
  • This new therapeutic option could help the 67-85% of COVID-19 patients admitted to the intensive care unit who suffer from acute respiratory distress syndrome,1 potentially reducing the need for mechanical ventilation and potentially saving lives.
  • The initiation of this Phase 2 trial is part of Boehringer Ingelheim’s ongoing efforts to accelerate the discovery and development of urgently needed medicines for COVID-19 patients.

Ingelheim, Germany – 28 October 2020 – 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: clinicaltrials.gov and mystudywindow.com.

About Boehringer Ingelheim
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

More information about Boehringer Ingelheim can be found at www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

Categories

  • Advocacy
  • Community Partners
  • FSR Events
  • Living with Sarcoidosis
  • News
  • Online Educational Content
  • Other
  • Patient Voices
  • Research
  • Take Action
  • Team KISS

Recent Posts

  • Rare Disease Legislative Advocacy
  • FSR Welcomes New Members to its Board of Directors
  • Becoming an FSR Patient Navigator: Stories of Resilience and a Desire to Make a Difference
  • February Cardiac Sarcoidosis Webinars
  • Emotional and Mental Health Wellness Series

Join Our Community

  • By checking the box below, you consent to receiving monthly email updates from FSR, as well as occasional additional announcement emails.
  • This field is for validation purposes and should be left unchanged.

Foundation For Sarcoidosis Research

1820 W. Webster Ave., Ste 304
Chicago, Illinois 60614

Phone: 312-341-0500

Recent Tweets

Follow @StopSarcoidosis

FSR
@StopSarcoidosis

  • No one knows exactly what causes #sarcoidosis, although our understanding of the mechanisms by which it develops is… twitter.com/i/web/status/1…
    about 11 hours ago

Help find a cure for tomorrow Donate

  • About Us
  • What We Do
  • Our Board of Directors
  • Scientific Advisory Board
  • Staff
  • Patient Ambassadors
  • What is Sarcoidosis?
  • Physicians Directory
  • Our Approach

Recent Tweets

Follow @StopSarcoidosis

FSR
@StopSarcoidosis

  • No one knows exactly what causes #sarcoidosis, although our understanding of the mechanisms by which it develops is… twitter.com/i/web/status/1…
    about 11 hours ago
  • Privacy Statement
  • SAB Statement
  • Site Map
  • FSR Industry Collaboration Policy

Copyright 2021 Foundation for Sarcoidosis Research | All Right Reserved