The US Food and Drug Administration (FDA) has granted Fast Track Designation to INBRX-101, an engineered recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein being developed by Inhibrx for the treatment of patients with emphysema due to alpha-1 antitrypsin deficiency (AATD). INBRX-101 therapy aims to safely achieve and maintain the levels of the AAT protein found in…
The 2023 conference of the American Thoracic Society (ATS) kicked off with a call to action on reducing air pollution and global warming.
A phase 2, double-blind, randomized, active-control, parallel group study comparing INBRX-101 with plasma-derived alpha1-proteinase inhibitor (A1-PI) augmentation therapy in patients with alpha-1 antitrypsin deficiency (AATD) with emphysema is currently recruiting. The study, known as ELEVAATE, will enroll approximately 90 adults (18-80 years old), males or females, with a confirmed diagnosis of AATD and evidence of emphysema secondary to…
In patients with alpha-1 antitrypsin deficiency (AATD), recent studies have revealed the association of the disorder with small airway dysfunction, according to findings published recently in Respiratory Medicine. The serine protease inhibitor alpha-1 antitrypsin (a1-AT), which is synthesized in the liver and then secreted into the bloodstream, reaches the lung by passive diffusion. The role…
The new ElevAATe trial for INBRX-101, an optimized recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, set to investigate its effectiveness in patients with emphysema due to alpha-1 antitrypsin deficiency (AATD), will start soon, Inhibrx announced. The biopharmaceutical company also stated that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on…
Nebulization may be an effective way to administer alpha-1 antitrypsin (AAT) directly to the lungs of patients with alpha-1 antitrypsin deficiency (AATD), according to a study published in Drug Delivery and Translational Research. The researchers compared the in vitro effectiveness of 2 commercially available inhalation systems: a jet and a mesh vibrating system, both used with…
Arrowhead Pharmaceuticals announced the first patient treated in Takeda’s phase 3 REDWOOD trial of fazirsiran (TAK-999/ARO-AAT) for patients with alpha-1 antitrypsin deficiency (AATD)-associated liver disease (AATD-LD). The study start, announced via news release, triggered a $40 million payment from Takeda to Arrowhead. AATD is a rare autosomal dominant condition in which a genetic mutation leads…
Among individuals with alpha-1 antitrypsin deficiency (AATD), the prevalence of fibrosis is high and rises incrementally with the number of Pi*Z mutations, according to findings from a systematic review and meta-analysis published in Alimentary Pharmacology & Therapeutics. Although recent data imply that a considerable percentage of adults with AATD have significant liver fibrosis, the prevalence…
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have provided a clear path forward for Mereo BioPharma’s investigational oral neutrophil elastase inhibitor, alvelestat (MPH-966). The regulatory feedback followed end-of-phase 2 meetings regarding the alvelestat program for the treatment of alpha-1 antitrypsin deficiency (AATD)-associated lung disease (AATD-LD). “We are very pleased…
A new study has determined that individuals with alpha-1 antitrypsin deficiency (AATD) and of European ancestry may not be at greater risk of contracting SARS-COVID-2 than the general population. The study, published in the Journal of Thoracic Diseases, also found no greater risk of disease severity or death in this patient population. The research team…
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