Non-cystic fibrosis bronchroid dilation (NCFBE) breakthrough drug! The pioneering DEP1 inhibitor brensocatib significantly reduces the risk of lung increase!

!--, 2020 // -- Insmed is a global biopharmaceutical company dedicated to changing the lives of people with severely rare diseases.
recently, the company announced that the final results of a study evaluating brensocatib (formerly INS1007) for the treatment of non-cystic fibrosis bronchid dilation (NCFBE) II will be published in the New England Journal of Medicine (NEJM).
data from the study's subgroup analysis were also presented on the same day at an online meeting of the 2020 annual meeting of the European Respiratory Society (ERS).
brensocatib is a new, pioneering (first-in-class), oral, reversible, dipeptide peptidease 1 (DPP1) inhibitor that is currently being developed for the treatment of bronchial dilation and other inflammatory diseases.
the United States, Brensocatib has been granted breakthrough drug eligibility (BTD) for the treatment of adult NCFBE to reduce the deterioration of the disease.
, there is no treatment specifically for NCFBE.
WILLOW study, Brensocatib significantly reduced the risk of lung increase in NCFBE patients compared to placebo.
findings are critical given the vicious cycle of inflammation, lung damage and infection, as well as the current lack of approved medications.
WILLOW is a global, randomized, double-blind, placebo-controlled Phase II study that evaluates the efficacy and safety of Brensocatib in treating adult NCFBE patients.
results showed that the study reached its main endpoint: 2 doses (10mg and 25mg) of brensocatib significantly extended the time of first lung exacerbation during treatment for 24 weeks (6 months) compared to placebo (10mg group p=0.03; 25mg group p=0.04).
At any time during the trial period, the 10mg group had a 42% reduction in the increased risk compared to the placebo group (HR=0.58, p=0.03) and the 25mg group had a 38% reduction in the increased risk compared to the placebo group (HR=0.62, p=0.046).
, brensocatib significantly reduced the risk of lung exacerbation compared to placebos (a key secondary endpoint of the study).
the specific data were: the 10mg and 25mg groups had a 36 per cent reduction in lung exacerbation and 25 per cent (p=0.04) and 25 per cent (p=0.17) respectively compared to the placebo group.
, the concentration of active neutrino elastinase (NE) in sputum was reduced compared to placebo during 24 weeks of treatment.
important, the results were consistent across subgroups based on age, baseline NE concentration, past history of exacerbation, bronchial dilation severity index, and lung function.
Dr James Chalmers, professor of respiratory medicine and consultant physician at the University of Dundee School of Medicine in the UK and lead author of the NEJM paper, said: "THE WILLOW study showed that in NCFBE patients with a history of frequent exacerbations, brensocatib treatment significantly extended the time of first exacerbation and reduced the risk of exacerbation throughout treatment.
the annualization rate was also lower than that of placebo.
these results are critical given the lack of approved drug therapies to reduce morbidity and mortality in patients with bronchiosis.
results also validate the new mechanism of action of brensocatib and highlight the potential benefits of reducing the activity of the neutral granulocyte serine protease.
", in addition to the findings published in NEJM, new data from the WILLLOW study were presented at the ERS International Conference.
subgroup analysis showed that
subgroups analyzed based on baseline disease severity, copper-green prosthetic monocytobacteria infection, and sputum NE concentration analysis of the patient subgroup, brensocatib continued to extend the first increase time, reducing the exacerbation rate.
addition, brensocatib reduced the concentration of all three neutrinocytes (NSPs) in the sputum (NE, protease 3, and tissue protease G).
the WILLOW study, the overall tolerance of brensocatib was good.
11%, 7% and 7%, respectively, in patients treated with placebo, brensocatib 10 mg and 25 mg.
most common adverse reactions in patients treated with brensocatib were coughing, headache, increased sputum, difficulty breathing, aggravated infectious bronchopneum expansion, and diarrhea.
non-cystic fibrosis bronchid dilation (NCFBE) is a serious chronic lung disease that permanently expands due to the circulation of infection, inflammation and lung tissue damage.
the disease is characterized by frequent lung deterioration and requires antibiotic treatment and/or hospitalization.
symptoms include chronic coughing, excessive sputum secretion, shortness of breath and recurrent respiratory infections, which can worsen underlying diseases.
NCFBE affects about 34-52 million patients in the United States.
currently, in the United States, Europe, Japan, there is no treatment specifically for NCFBE brensocatib is a small molecule developed by Insmed oral reversible dipeptidease I (DPP1) inhibitor for the treatment of bronchial dilation.
DPP1 is an enzyme that activates neutral granulocyte serine protease (NSP), such as neutral granulocyte elastinase, when it is formed in the bone marrow.
are the most common type of white blood cells and play an important role in pathogen destruction and inflammatory regulation.
in chronic inflammatory lung disease, neutrogenic granulocytes accumulate in the airways, causing overactive NSPs that cause lung damage and inflammation.
brensocatib may reduce the damaging effects of inflammatory diseases such as bronchal dilation by inhibiting DEP1 and its activation of NSP.
Insmed expects to launch Phase III of brensocatib's treatment of bronchia expansion in the second half of 2020.
() !--/ewebeditor:page--!--ewebeditor:page-title"--the original source: England Journal of Medicine Publishes Positive Results from Phase 2 WILLOW Study Study Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis !--/ewebeditor:page