ReAlta Life Sciences Reports Positive Preclinical Data for RLS-0071 in aGVHD at ASH Annual Meeting

ReAlta Life Sciences, Inc., a biopharmaceutical company in the clinical stage, is focused on saving lives by addressing rare and acute inflammatory diseases through rebalancing the inflammatory response. Recently, ReAlta has announced promising preclinical results for its leading asset, RLS-0071 (pegtarazimod), in treating acute Graft-versus-Host Disease (aGVHD). These findings will be showcased in a poster session at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, California.

The study, led by Dr. Robert Zeiser at the University of Freiburg, highlighted that pegtarazimod considerably improved survival rates in various mouse models of aGVHD. The effect was observed both when the drug was used as a preventive measure and as a treatment. In prevention models using a major histocompatibility complex (MHC)-mismatch, pegtarazimod administered from Days 0-7 significantly increased the overall survival rate to Day 60 compared to the control group. Additionally, early intervention starting on Day 7 also notably enhanced survival for mice that developed aGVHD.

Dr. Robert Zeiser, a Professor of Medicine at the University of Freiburg's Department of Hematology, Oncology, and Stem Cell Transplantation Medical Center, commented on the significance of these findings. He noted the drug's protective impact on intestinal tissue in mice, which is crucial since intestinal complications are a major cause of mortality in aGVHD patients.

The study demonstrated that pegtarazimod works through multiple mechanisms to mitigate inflammation and tissue damage. Treatment with the drug significantly reduced serum levels of myeloperoxidase (MPO) and neutrophil elastase by approximately 50%, indicating a decrease in neutrophil activation and inflammation. Previous research by Dr. Zeiser's lab had shown the role of neutrophils in contributing to GVHD in mouse models. In splenic neutrophils, pegtarazimod led to significant reductions in several inflammatory markers, including TNF, IL-1β, and MCP-1/CCL2. Additionally, in lab-grown intestinal tissue (organoids), the drug showed substantial protective effects under inflammatory conditions, enhancing viability by around 40% and reducing cell damage by 25%, as measured by lactate dehydrogenase (LDH) release, a marker of cell death and tissue injury. Histological analysis further revealed a significant reduction in GVHD scores across multiple organs, particularly in the colon, liver, and small intestine, in both preventive and early intervention studies.

Paolo Martini, Ph.D., Chief Research and Development Officer of ReAlta, highlighted the drug's dual mechanism targeting both complement and neutrophil-mediated inflammation at critical points in the inflammatory pathway. He emphasized that these results support the therapeutic potential of pegtarazimod as the company advances its Phase 2 trial to address the unmet needs in aGVHD treatment.

ReAlta is currently conducting a Phase 2, open-label clinical trial of RLS-0071 in patients with steroid-refractory aGVHD at clinical sites across the United States, Germany, and Spain.

ReAlta Life Sciences, Inc. focuses on lifesaving treatments by rebalancing the inflammatory response to tackle rare and acute inflammatory diseases. The Company's EPICC peptide platform stems from discoveries related to the human astrovirus, HAstV-1, which inhibits innate immune system components, a trait unique among viruses. By targeting both the complement cascade and key neutrophil-driven inflammation mechanisms, ReAlta's therapeutic peptides leverage this virus's evolutionary adaptations to modulate inflammatory pathways effectively. The lead candidate, RLS-0071 (pegtarazimod), has received several designations from the FDA and the European Medicines Agency for treating various conditions, including hypoxic ischemic encephalopathy (HIE) and acute exacerbations of chronic obstructive pulmonary disease (COPD). ReAlta was founded in 2018 and operates in Norfolk, Virginia, and Aguadilla, Puerto Rico.