Phase III InPedILD™ trial enrolls first patient to evaluate nintedanib in pediatric population with fibrosing interstitial lung disease

Ingelheim, Germany,
  • First-of-its-kind clinical trial in children and adolescents with fibrosing interstitial lung disease (ILD) initiated globally
  • This new study builds on the Phase III INBUILD® trial and approval of Ofev® in adult patients with fibrosing ILDs with a progressive phenotype1,2,3
  • Global Phase III multicentre clinical trial is planned to be conducted in approximately 70 sites in 24 countries
 
Ingelheim, Germany, 12 August 2020 – Boehringer Ingelheim today announced that the first patient has enrolled in InPedILD™, a global Phase III trial assessing the dosing and safety profile of nintedanib in children and adolescents between six and 17 years old with clinically significant fibrosing interstitial lung disease (ILD).
 
Childhood ILD (chILD) includes more than 200 rare respiratory disorders that can affect infants, children and adolescents, making it difficult for them to breathe. In some cases, fibrosis which involves scarring and damage to the lungs can develop. This can lead to a significant impact on the daily life of those affected, as well as their families, including high morbidity and mortality. There are currently no approved therapies available for the treatment of chILD.  
 
“Some children with interstitial lung disease may develop serious fibrosis that progresses,” said the coordinating investigator Prof. Robin Deterding, M.D., Director of the Breathing Institute, Children's Hospital Colorado. “Though the underlying causes of pulmonary fibrosis may be different in children, we’re excited to determine if treating the mechanism of fibrosis improves children’s lung fibrosis as it does in adults.”
 
Nintedanib, which is marketed as Ofev®, is currently approved in more than 80 countries for the treatment of people living with idiopathic pulmonary fibrosis (IPF).4 It is also approved in more than 40 countries as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD (SSc-ILD).5 Ofev® recently also obtained approval in the USA, Canada, Japan, Brazil, Argentina and the EU, for a third indication, as the first and only treatment for patients living with chronic fibrosing ILDs with a progressive phenotype.2,3
 
“Boehringer Ingelheim is proud to start this trial to provide valuable insights as we evaluate this potential treatment  for children and adolescents with these rare and heterogenous conditions for which there are currently no treatments with proven efficacy and no randomized controlled trials,” said Dr Susanne Stowasser, Associate Head of Medicine Pulmonology at Boehringer Ingelheim. “This study represents our ongoing commitment to address unmet needs and advance research for adult and pediatric patients living with pulmonary fibrosis.”
 
About InPedILD™
This double-blind, randomized, placebo-controlled, multicenter international Phase III trial [NCT04093024] will enroll patients in approximately 70 sites in 24 countries. The study, in children and adolescents (six to 17 years old) with clinically significant fibrosing ILD, will evaluate the dose-exposure and safety of nintedanib, administered orally on top of usual care for 24 weeks, followed by open-label treatment with nintedanib of variable duration. The primary endpoints are blood concentration of nintedanib at week two and week 26, and the number of patients with treatment-emergent adverse events (TEAE) at week 24. Secondary endpoints, among others, include change in forced vital capacity (FVC) percent predicted from baseline at week 24 and week 52, which is an established measurement of lung function; absolute change from baseline in health-related quality of life, as measured by the Pediatric Quality of Life Questionnaire™ (PedsQL™) at week 24 and week 52; time to first respiratory-related hospitalization over the whole trial; and time to first acute ILD exacerbation or death over the whole trial. For more information about the trial, please visit the website.
 
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.
 
Intended audiences
This press release is issued from our corporate headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

References

1. Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in progressive fibrosing interstitial lung diseases. N Engl J Med. 2019;381(18):1718-1727. doi: 10.1056/NEJMoa1908681.
2. European Commission decision, July 13, 2020. Data on file.
3. U.S. Food and Drug Administration news release. FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-group-progressive-interstitial-lung-diseases. Last accessed August 2020. 
4. European Summary of Product Characteristics Ofev®, July 13, 2020. Data on file. 
5. U.S. Food and Drug Administration news release. FDA approves first treatment for patients with rare type of lung disease. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-rare-type-lung-disease. Last accessed August 2020.References

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