Inhibrx Granted FDA Fast Track Designation for INBRX-101
30 May 2023 - 11:46PM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
May 30, 2023 09:31 ET (13:31 GMT)
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