Inhibrx begins registration-enabling trial of AATD candidate, resumes Phase 1

Inhibrx has initiated a registration-enabling trial for INBRX-101, an optimized recombinant human AAT-Fc fusion protein, for treatment of patients with emphysema due to alpha-1 antitrypsin deficiency – AATD -. Additionally, the company announced that the FDA has lifted the partial clinical hold on studies evaluating its death-receptor 5 agonist, INBRX-109. The ElevAATe trial is designed as a randomized, controlled, double-blind, head-to-head superiority study examining INBRX-101 against plasma-derived AAT. The primary endpoint of the trial is the mean change in the average functional AAT concentration. The initial read-out from the ElevAATe trial is expected to occur in late 2024. In March 2023, the Company announced the pause in patient enrollment for the INBRX-109 trials as a result of the pre-defined stopping rules built into the Phase 2 protocol. In April 2023, the FDA lifted the partial clinical hold. Patient enrollment is expected to resume next month. Phase 1 combination cohorts are expected to begin reading out by the end of 2023 and data from the registration-enabling trial in unresectable or metastatic conventional chondrosarcoma is expected during the second half of 2024.