The new ElevAATe trial for INBRX-101, an optimized recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, set to investigate its effectiveness in patients with emphysema due to alpha-1 antitrypsin deficiency (AATD), will start soon, Inhibrx announced.
The biopharmaceutical company also stated that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on studies evaluating INBRX-109, the death-receptor 5 agonist of INBRX-101.
“In March 2023, the patient enrollment for the INBRX-109 trials was paused as a result of the pre-defined stopping rules built into the Phase 2 protocol. Patient enrollment is expected to resume next month,” Inhibrx officials stated.
The ElevAATe trial is a randomized, controlled, double-blind, head-to-head superiority study that will examine the effectiveness of INBRX-101 against plasma-derived AAT. It will be conducted at approximately 35 sites in the United States, Australia, and New Zealand.
Read more about AATD experimental therapies
According to the study protocol, the first group of 36 patients with AATD will receive 120 mg/kg of INBRX-101 once every 3 weeks, the second group of 36 patients with AATD will receive the same dose of the experimental medication once every 4 weeks, and the third group consisting of 18 patients with AATD will be given plasma-derived AAT at the FDA-approved dose every week. The treatment period will last 32 weeks.
The researchers will evaluate the mean change in the average functional AAT (fAAT) concentration as measured by antineutrophil elastase capacity from baseline to average serum through fAAT concentration at a steady state as the primary outcome measure.
The secondary endpoints will include a comparison of the mean change in fAAT concentration from baseline to fAAT average concentration at steady state and the percentage of days with fAAT above the lower limit of the normal range during steady-state dosing.
Initial data is expected to be revealed in the second half of 2024. A bronchoscopy substudy of approximately 30 patients will also be conducted at some study sites.
Inhibrx initiates a registration-enabling trial of INBRX-101 in AATD and announces lift of partial clinical hold on INBRX-109 DR5 agonist trials. News release. Inhibrx Inc.; April 26, 2023.