Inhibrx's INBRX-101 Shows Favorable Safety Profile In An Inherited Disorder

Inhibrx Inc INBX announced topline results from a Phase 1 clinical trial of INBRX-101, an optimized recombinant human AAT-Fc fusion protein, in patients with alpha-1 antitrypsin deficiency (AATD).
AATD is an inherited condition that raises lung and liver disease risks. AAT is a protein that protects the lungs, and the liver makes it.
Treatment was well tolerated, with no severe or serious adverse events related to the study drug.
Related: Inhibrx Shares Interim Data On INBRX-106 - Keytruda Combo Therapy In Solid Tumors.
Drug-related adverse events were predominantly mild, and those few that were moderate in severity were all transient and reversible, with minimal or no symptomatic care.
No safety-related or PK/PD-related signs of neutralizing anti-drug antibodies were observed.
Data from the multiple ascending dose cohorts of INBRX-101 at 40, 80, and 120 mg/kg IV every three weeks showed the expected accumulation of functional AAT levels.
The current standard of care, plasma-derived AAT, dosed once weekly at 60 mg/kg, achieves a Cavg of functional AAT of 17.8 µM over the weekly dosing interval.
INBRX-101 achieved a mean Cavg of functional AAT of 40.4 µM over the 21-day dosing interval following the third 80 mg/kg dose.
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