Mark L Brantly, Brooks T Kuhn, Humam W Farah, Ravi Mahadeva, Alexandra Cole, Catherina L Chang, Cynthia D Brown, Michael A Campos, Jorge E Lascano, Erin K Babcock, Sharvari P Bhagwat, Teresa F Boyea, Carson A Veldstra, Vasily Andrianov, James L Kalabus, Brendan P Eckelman, Andrew G Veale
BACKGROUND: Alpha-1 antitrypsin deficiency (AATD) is characterized by low alpha-1 antitrypsin (AAT) levels, predisposing individuals to lung disease. The standard of care, plasma-derived AAT (pdAAT), is delivered as weekly infusions to maintain serum AAT concentrations ≥11µM (≈50% of those in healthy individuals). INBRX-101, a recombinant human AAT-Fc fusion protein, was designed to have a longer half-life and achieve higher AAT levels than pdAAT. METHODS: In this phase 1 dose-escalation study (N=31), adults with AATD received 1 dose (part 1) or 3 doses (part 2) of 10 (part 1), 40, 80, or 120mg/kg INBRX-101 every 3 weeks (Q3W) via intravenous infusion...
May 29, 2024: Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation