AstraZeneca sold small molecule brensocatib approved by FDA breakthrough therapy!

NCFBE is a serious chronic lung disease that causes permanent expansion of the bronchial tube due to the recurrence of infection, inflammation and pulmonary tissue damageThe disease is typically characterized by frequent pulmonary exacerbations that cause patients to require antibiotics and/or hospitalizationClinical symptoms include chronic cough, excessive sputum, shortness of breath, and repeated respiratory infections, which can also have a potential impact on disease exacerbationNCFBE affects the U.Spopulation of about 340,000 to 520,000Currently, there are no specific treatments for NCFBE approved in the United States, Europe and JapanBrensocatib Structure
Brensocatib is a new type of oral reversible dipeptide peptidease 1 (DPP1) inhibitor that has been developed by Insmed to treat bronchodilatal diseases and other inflammatory diseasesDPP1 is responsible for activating neutrophil serine protease (NSP), such as neutrophil elastinase, which promotes neutrophil formation in the bone marrowNeutrophils are the most common white blood cell type and play a vital role in pathogen destruction and inflammatory mediaIn chronic inflammatory lung disease, neutrophils accumulate in the airways and cause An overdose of NSP, leading to lung damage and inflammationBrensocatib can reduce the destructive effects of inflammatory diseases such as bronchial dilation by inhibiting DPP1 activity and activating NSPsBrensocatib was first discovered by AstraZeneca, which transferred its global exclusive interest to Insmed in a deal on October 5, 2016, for a $30 million down payment and $120 million in mileageAstraZeneca will in the future be entitled to a share of Brensocatib-based sales revenue and the right to negotiate with Insmed the right to commercially promote brensocatib in the areas of COPD and asthmaFDA awarded brensocatib breakthrough therapy based primarily on positive results of the global multicenter, randomized, double-blind, placebo-controlled PHASE II WILLOW trialThe WILLOW trial involved 256 adult NCFBE patients at 116 centers worldwide who recorded lung deterioration more than 2 times before screening, given 10mg, 25mg or placebo, in a 1:1:1 group, respectivelyThe main endpoint was the time difference between the first lung deterioration in the drug administration group and the control group during the 24-week treatment period Insmed has announced that it will announce the results of the WILLOW trial at the US Thoracic Annual Meeting (ATS) on June 24 In addition, Insmed plans to launch a phase III study of bronchial dilation in brensocatib in the second half of 2020 Martina Flammer, Chief Medical Officer, Insmed, said, "It's great to see brensocatib's access to the FDA's breakthrough treatment of NCFBE, which reflects the strength of our Phase II clinical data and the promise of brensocatib to provide a first in class innovative therapy for bronchodilating patients." NCFBE is currently unapproved in the U.S., Europe and Japan, and we look forward to working closely with the FDA to advance the clinical development of brensocatib to meet the clinical needs of these patients original title: AstraZeneca sold small molecules approved by FDA Breakthrough Therapy! Promising to become a first in class bronchial dilating drug