New drug for fibrosis interstitia pulmonary disease (ILD)! Bringer Ingham Ofev (Nidanib) launches the Pediatrics Global Phase III study!

August 13, 2020 // -- Boehringer Ingelheim recently announced the first case of InPedILD (NCT04093024) in a global phase III clinical study of patients treated with interstitiotic pulmonary disease (IDL) in Ofev (Chinese: Vegat, common name: nintedanib, Nidanib).
InPedILD is a randomized, double-blind, placebo-controlled, multi-center International III study that will recruit patients at approximately 70 clinical trial points in 24 countries around the world.
The study, which will include patients with ID (6-17 years of age) with clinically significant fibrosis, will assess Ofev's dose exposure and safety, take the drug orally for 24 weeks on a routine basis, and then use Ofev for different durations for open label therapy.
main endpoints were Ofev's blood concentration at weeks 2 and 26, and the number of patients who experienced TEAE (adverse events in treatment) at week 24.
It's worth noting that InPedILD is the world's first clinical trial of ILD for children and adolescents, based on Ofev's Phase III INBUILD trial and regulatory approval for adult patients with aggressive esoteric fibrosis ILD (PF-ILD) to address the unsatisfying and important needs of the most vulnerable pediatric patient population affected by ILD.
children's IILD (chILD) includes more than 200 rare respiratory diseases that affect infants, children and adolescents and make it difficult for them to breathe.
, fibrosis can develop into scarring and lung damage.
may have a significant impact on the daily lives of those affected and their families, including high morbidity and mortality.
currently, there is no approved treatment for CHILD.
children with ILD may develop severe fibrosis and develop further," said Dr. Robin Derting, M.D., co-researcher of the InPedILD study and director of the Respiratory Research Institute at Children's Hospital of Colorado.
although the underlying causes of pulmonary fibrosis may vary in children, we are pleased to determine whether Ofev's mechanisms for treating fibrosis can improve pulmonary fibrosis in children as much as in adults.
Ofev is a multi-target tyrosine kinase inhibitor that inhibits the key path of pulmonary fibrosis in interstitific pulmonary disease (ILD).
To date, Ofev has approved three adaptations: (1) for the treatment of idiopathic pulmonary fibrosis (IPF);(2) for the treatment of systemic sclerosis-related interstitiopathic pulmonary disease (SSc-ILD) ;(3) for the treatment of other chronic fibrosis interstitiopathic pulmonary disease (PF-ILD) with an aggressive ideotype other than IPF.
Ofev is the only treatment that slows the decline in lung function in SSc-ILD patients and the only one approved for PF-ILD.
in China, Ofev has been approved to treat IPF and SSc-ILD, and applications for treatment of PF-ILD were accepted by the State Drug Administration late last year. Dr Thomas Leonard, Executive Director of Clinical Development and Medical Affairs at
Bronger Ingeham Professional Care IPF/ILD, said: "We are encouraged by these findings related to the decline in lung function in patients with developing chronic fibrous ILD (PF-ILD) who are helping to support the growing scientific evidence for the use of Ofev.
" ILD (Photo: pulmonaryfibrosisnews.com) In July, Ofev was approved by the European Union to treat PF-ILD.
the approval is based on the results of the Phase III INBUILD study, the first clinical study to reach a major endpoint in the IILD patient population.
the study, a randomized, double-blind, placebo-controlled, parallel group study conducted at 153 clinical centers in 15 countries, assessed the efficacy, safety and tolerance of Ofev (150 mg, 2 times a day) for 52 weeks of treatment in PF-ILD patients.
study, 663 patients were evaluated, of which 412 (62.1%) showed changes in interstitity pneumonia (UIP) on high-resolution computer fault scans (HRCT).
patients were randomly grouped according to the fibrosis pattern detected by HRCT, and lung function was assessed by the annual decrease rate of forced lung capacity (FVC).
results showed that FVC decreased by 188 ml in placebo group patients and 81 ml in Ofev group patients at 52 weeks of treatment.
this meant that Ofev slowed lung function by 57% (107 ml/year) compared to a placebo.
the study, Ofev's treatment for reduced lung function was consistent across all patients, regardless of fibrosis patterns on HRCT, and consistent with Ofev's trial results in patients with IF and SSc-ILD.
specifically, in patients with UIP-like fibrosis shown on HRCT, Ofev's treatment slowed lung function by 61% (128.2 ml/year) compared to placebo.
study, Ofev was associated with a lower risk of acute exacerbation or death than a placebo.
treatment was accompanied by a decrease in the deterioration of patients' reported outcomes, such as breathing difficulties and coughing.
the safety observed in the study was consistent with clinical trials of IF and SSc-ILD, with the most common adverse events being diarrhoea, with the incidence rates in the Ofev treatment group and the placebo group at 66.9% and 23.9%, respectively.
() Original origin: Phase III InPedILD™ trial enrolls first patient to evaluate nintedanib in pediatric population with fibrosing interstitial lung disease.