Inhibrx's Experimental Drug For Inherited Disease Capable For Accelerated FDA Approval, Shares Surge

  • Based on discussions with the FDA, Inhibrx Inc INBX has the potential to pursue accelerated approval for INBRX-101 for emphysema due to alpha-1 antitrypsin deficiency (AATD) using functional alpha-1 antitrypsin (AAT) serum levels as the surrogate endpoint. 
  • Inhibrx also detected INBRX-101 in the bronchoalveolar lavage fluid (BALF) samples from all AATD patients tested in the Phase 1 study.
  • Related: Inhibrx's INBRX-101 Shows Favorable Safety Profile In An Inherited Disorder.
  • Inhibrx plans to initiate in Q1 of 2023 a potential registration-enabling trial using functional AAT as a surrogate endpoint.
  • Based on data from the completed Phase 1 study, INBRX-101 is predicted to maintain patients above the lower threshold of the normal range and achieve an average level of functional AAT.
  • The FDA also requested additional data on the correlation between functional AAT levels and the clinical benefit of AATD to further support serum AAT levels as a surrogate endpoint that is reasonably likely to predict clinical benefit.
  • Price Action: INBX shares are up 30.9% at $26.41 during the premarket session on the last check Tuesday.
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