Boehringer Ingelheim has reported findings from the Phase III InPedILD clinical trial of nintedanib to treat fibrosing interstitial lung disease (ILD) in children and adolescents aged six to 17 years.
The randomised, double-blind, placebo-controlled trial analysed the dose exposure and safety of nintedanib given along with a standard of care for 24 weeks.
Trial subjects aged six to 17 years with clinically significant fibrosing ILD also received open-label treatment with nintedanib for a variable time period.
According to the pharmacokinetic data, the exposure to nintedanib in children was within the variability of that seen in adults who received the approved treatment dose.
This supports the usage of a weight-based dosing schedule in the paediatric population.
Nintedanib was found to have a favourable safety and tolerability profile.
No new safety signals were seen in InPedILD trial subjects versus adults with idiopathic pulmonary fibrosis (IPF) or other progressive fibrosing and systemic sclerosis-associated ILD (PF-ILD and SSc-ILD).
The proportion of subjects with treatment-emergent adverse events at week 24 was considered as the basis for the safety endpoint.
Consistent with adults, diarrhoea was reported to be the most common adverse event linked to nintedanib in this trial.
Based on the latest data, the company plans to file regulatory applications with the European Medicines Agency and the US Food and Drug Administration.
On obtaining approval, nintedanib could become the first treatment for use in the paediatric population with fibrosing ILD.
A tyrosine kinase inhibitor, nintedanib acts on crucial receptors linked to signalling pathways that cause pulmonary fibrosis.
Boehringer Ingelheim Medicine Pulmonology associate head Dr Susanne Stowasser said: “While childhood interstitial lung diseases are very rare, their impact on children, teenagers, and their loved ones can be devastating.
“The findings from InPedILD help meet the urgent need for well-characterised therapies for these children and adolescents living with ILD.”
In May this year, the company reported findings from a Phase II trial where its investigational therapy BI 1015550 showed a reduction in the rate of decline in lung function in IPF patients.