PORTLAND, Ore., July 19, 2021 /PRNewswire/ -- Aronora Inc., a clinical stage biotechnology company developing paradigm shifting therapies for serious hematologic diseases, today announced positive topline data from the Company's randomized placebo-controlled phase 2 clinical trial testing AB023 in end-stage renal disease patients on heparin-free hemodialysis. AB023 is a recombinant antibody that specifically inhibits reciprocal activation of coagulation factors XI (FXI) and XII (FXII) without blocking the hemostatic activity of FXI, which is necessary for normal bleeding control. This unique characteristic of AB023 differentiates it from all other FXI inhibitors in commercial development. In the phase 2 trial, patients were randomized to receive a single pre-dialysis dose of AB023 (0.25 or 0.5 mg/kg) or placebo. AB023 administration was not associated with increased bleeding at the vascular access site, or with any other drug-related adverse events. Occlusive clotting events that required hemodialysis circuit change-out were less frequent, and biomarkers of thrombosis and inflammation were lower after AB023 administration compared with pre-dosing levels. AB023 also reduced blood entrapment within the dialyzers, consistent with less blood clotting.
"This is an extremely exciting outcome, as it shows that our innovative drug candidate could safely reduce device-initiated blood clotting in a medically complex patient population, and expands the body of evidence supporting this unique mechanism of action," said Erik Tucker, Chief Operating Officer of Aronora. "These clinical data continue to build evidence that AB023 has the potential to be a best-in-class agent in terms of safety and efficacy for preventing or treating thrombotic disorders."
Full results of the study have been pre-published online in the journal Blood, the most cited peer-reviewed publication in the field of hematology. Clinical trial data will also be presented at the XXIX Congress of the International Society on Thrombosis and Haemostasias (ISTH), taking place virtually July 17-21, 2021. Details of the oral presentation are as follows:
- Title: A Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating Safety and Efficacy of AB023 in Hemodialysis Patients
- Abstract Number: OC60.1
- Session: OC60 Anticoagulants: Novel Strategies and Mechanisms
- Session Date: Wednesday, July 21
- Session Time: 10:00 AM-11:00 AM (EDT)
- Presentation Time: 10:00 AM (EDT)
- Abstracts are available via the ISTH meeting website
Additional information about the trial can be found at ClinicalTrials.gov. Preclinical and early clinical development of AB023 has been partially supported by the National Heart, Lung, and Blood Institute and National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH). This content is solely the responsibility of Aronora and does not necessarily represent the official views of the NIH. For more information, visit www.aronorabio.com.
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SOURCE Aronora, Inc