Phase III InPedILD trial enro

• 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 phenotype^1,2,3

• Global Phase III multicentre clinical trial is      planned to be conducted in approximately 70 sites in 24 countries

INGELHEIM, Germany -- (BUSINESS WIRE) --

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.”

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