Inhibrx Granted FDA Fast Track Designation for INBRX-101

By Chris Wack

Inhibrx said Tuesday that the U.S. Food and Drug Administration granted Fast Track designation to INBRX-101, an optimized recombinant human AAT-Fc fusion protein, for the treatment of patients with emphysema due to alpha-1 antitrypsin deficiency.

Fast track designation is granted by the FDA upon a sponsor's request to speed up the development and review of drugs intended to treat serious or life-threatening diseases.

Investigational drug products with fast track designation may benefit from early and frequent communication with the FDA and are eligible for rolling submission and review of its future marketing application.

The clinical-stage biopharmaceutical company's study is a registration-enabling trial for INBRX-101, begun in April, and is designed as a head-to-head superiority study examining INBRX-101 against plasma-derived AAT.

The initial read-out from the trial is expected to occur in late 2024. The primary endpoint is the mean change in the average functional AAT concentration as measured by anti-neutrophil elastase capacity from baseline to average serum trough fAAT concentration at steady state.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

May 30, 2023 09:31 ET (13:31 GMT)

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