ReAlta Life Sciences, Inc.

NORFOLK, Va.--( BUSINESS WIRE )-- ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a clinical-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address rare and acute inflammatory diseases, today announced positive preclinical data for its lead asset RLS-0071 (pegtarazimod) in acute Graft-versus-Host Disease (aGVHD). These data will be presented in a poster session at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, California. The research, conducted in the laboratory of Dr. Robert Zeiser at the University of Freiburg, demonstrated that pegtarazimod significantly increased survival rates in multiple mouse models of aGVHD, showing effectiveness both when used preventively and as a treatment (Holzmüller V., et al. ASH 2024) . In prevention studies using a major histocompatibility complex (MHC)-mismatch model, pegtarazimod treatment from Days 0-7 improved overall survival to Day 60 compared to vehicle control. Early intervention treatment with pegtarazimod initiated on Day 7 also significantly improved survival of mice developing aGVHD. “These data demonstrate efficacy of pegtarazimod in both prevention and early intervention settings in mice developing acute GVHD,” commented Dr. Robert Zeiser, Professor of Medicine at the Department of Hematology, Oncology and Stem Cell Transplantation Medical Center, University of Freiburg. “Particularly noteworthy is pegtarazimod's protective effect on intestinal tissue in mice, as intestinal manifestations are a significant driver of mortality in aGVHD patients.” The study revealed that pegtarazimod works through several mechanisms to reduce inflammation and tissue damage. Treatment with pegtarazimod significantly reduced serum levels of myeloperoxidase (MPO), a key enzyme released by activated neutrophils, by approximately 50%, and neutrophil elastase levels by approximately 50%, indicating decreased neutrophil activation and inflammation. Prior work by the Zeiser laboratory had shown the neutrophils contribute to GVHD in the mouse model (Nature Med. 2014 Jun;20(6):648-54. doi: 10.1038/nm.3517) . In splenic neutrophils, pegtarazimod treatment resulted in significant reductions in multiple inflammatory markers, including TNF, IL-1β, and MCP-1/CCL2. In lab-grown intestinal tissue (organoids), pegtarazimod demonstrated significant protective effects under inflammatory conditions, improving viability by approximately 40% and reducing cell damage by 25% as measured by lactate dehydrogenase (LDH) release, a marker of cell death and tissue injury. Histological analysis revealed that pegtarazimod treatment significantly reduced GVHD scores across multiple organs in both prevention and early intervention studies, with particularly notable improvements in the colon, liver, and small intestine. “These results highlight pegtarazimod's unique dual mechanism to simultaneously target complement and neutrophil-mediated inflammation at the earliest and most destructive points in the inflammatory cascade,” said Paolo Martini, Ph.D., Chief Research and Development Officer of ReAlta. “These data add to the comprehensive body of research supporting pegtarazimod’s therapeutic potential, as we advance our Phase 2 trial on a path towards addressing the pressing unmet need in aGVHD.” ReAlta is currently enrolling a Phase 2, open-label clinical trial of RLS-0071 in patients with steroid-refractory aGVHD at clinical sites in the United States, Germany, and Spain. To learn more, visit: https://clinicaltrials.gov/study/NCT06343792 About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a clinical mid-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address life threatening rare and acute inflammatory diseases. The Company’s EPICC peptide platform is based on discoveries related to the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis by inhibiting components of the innate immune system – a trait unique among viruses. By inhibiting activation of the complement cascade and two key neutrophil-driven mechanisms of inflammation and host tissue destruction – myeloperoxidase (MPO) and neutrophil extracellular traps (NETs), ReAlta’s therapeutic peptides leverage the dual-targeting mechanisms of this human enteric virus – and its millions of years of evolutionary adaptations – to modulate both complement and innate inflammatory pathways. The Company’s pipeline is led by RLS-0071 (pegtarazimod), which has received both Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation by the European Medicines Agency, for the treatment of hypoxic ischemic encephalopathy (HIE), a devastating disease that causes brain damage in oxygen-deprived newborns and is a leading cause of cerebral palsy; Orphan Drug Designation and Fast Track Designation by the FDA for the treatment of acute graft-versus-host disease (aGVHD), a disease associated with bone marrow and stem cell transplants whereby transplanted white blood cells attack the new host in an inflammatory response; and IND clearance by the FDA for the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD), an inflammatory lung disease characterized by progressive airflow limitations and tissue destruction that makes it challenging for patients to breathe. The company launched in 2018 and is located in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit www.realtalifesciences.com .

NORFOLK, Va.--( BUSINESS WIRE )-- ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a clinical-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address rare and acute inflammatory diseases, today announced a poster presentation of its lead asset, RLS-0071 (pegtarazimod), will be presented at the 66 th American Society of Hematology (ASH) Annual Meeting & Exposition, being held December 7-10, 2024, in San Diego, California. ReAlta is developing pegtarazimod, a synthetic peptide derived from human astrovirus serotype 1, as a potential treatment for acute Graft-versus-Host Disease (aGVHD), a serious complication of allogeneic hematopoietic cell transplantation, as well as pulmonary and neurological conditions. Pegtarazimod is a dual-action anti-inflammatory agent that inhibits both the complement cascade and neutrophil-mediated inflammation. Pegtarazimod has previously demonstrated an excellent safety profile and target engagement in a Phase 1 study of healthy volunteers, with no treatment-related or serious adverse events reported. A Phase 2, open-label clinical trial of pegtarazimod for hospitalized patients with steroid-refractory aGVHD ( NCT06343792 ) is currently enrolling at clinical sites located within the United States, Germany and Spain. The data to be presented at the upcoming ASH meeting explores the underlying mechanisms of pegtarazimod in a preclinical model of aGVHD using different investigational methods. This data was generated from experiments conducted within the laboratory of Dr. Robert Zeiser at the University of Freiburg – one of the leading laboratories investigating the underlying pathogenesis and potential treatments for aGVHD. Poster presentation details: Title: Exploring a Novel Anti-Inflammatory Peptide as Potential Treatment for Acute Graft-Versus-Host Disease (aGVHD) Presenter: Verena Holzmüller, PhD candidate in the laboratory of Robert Zeiser, M.D., at the Spemann Graduate School of Biology and Medicine (SGBM), University of Freiburg Presentation: Poster #194793; Location San Diego Convention Center, Halls G-H Session: 701. Experimental Transplantation: Basic and Translational: Poster II Date/Time: Sunday, December 8, 2024, 6:00 PM - 8:00 PM The abstract can be accessed on the ASH website at https://www-hematology-org.libproxy1.nus.edu.sg/meetings/annual-meeting/abstracts . About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a clinical mid-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address life threatening rare and acute inflammatory diseases. The Company’s EPICC peptide platform is based on discoveries related to the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis by inhibiting components of the innate immune system – a trait unique among viruses. By inhibiting activation of the complement cascade and two key neutrophil-driven mechanisms of inflammation and host tissue destruction – myeloperoxidase (MPO) and neutrophil extracellular traps (NETs), ReAlta’s therapeutic peptides leverage the dual-targeting mechanisms of this human enteric virus – and its millions of years of evolutionary adaptations – to modulate both complement and innate inflammatory pathways. The Company’s pipeline is led by RLS-0071 (pegtarazimod), which has received both Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation by the European Medicines Agency, for the treatment of hypoxic ischemic encephalopathy (HIE), a devastating disease that causes brain damage in oxygen-deprived newborns and is a leading cause of cerebral palsy; Orphan Drug Designation and Fast Track Designation by the FDA for the treatment of acute graft-versus-host disease (aGVHD), a disease associated with bone marrow and stem cell transplants whereby transplanted white blood cells attack the new host in an inflammatory response; and IND clearance by the FDA for the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD), an inflammatory lung disease characterized by progressive airflow limitations and tissue destruction that makes it challenging for patients to breathe. The company launched in 2018 and is located in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit www.realtalifesciences.com .

NORFOLK, Va.--( BUSINESS WIRE )--ReAlta Life Sciences, Inc. ("ReAlta" or the “Company”), a clinical-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address rare and acute inflammatory diseases, today announced that the first patient has been dosed in its Phase 2 study of RLS-0071, the Company’s lead therapeutic candidate, for the treatment of hospitalized patients with moderate to very severe steroid-refractory acute graft-versus-host disease (aGvHD), a serious and often fatal complication following hematopoietic stem cell transplantation. “Hematopoietic stem cell transplantation is one of the most impactful treatments available for people with cancer, autoimmune disease, sickle cell disease and other life-threatening disorders. However, the procedure can quickly turn into a severe and life-threatening condition for those who are affected by acute graft-versus-host disease in which the transplanted immune cells attack the patient, leading to severe inflammation and tissue damage,” said ReAlta Chief Medical Officer Kenji Cunnion, MD, MPH. “We believe that RLS-0071 has the potential to be a powerful new tool to improve outcomes for individuals with this serious complication of transplantation. We aim to leverage RLS-0071's unique dual mechanism-of-action (MOA) to inhibit unwanted inflammatory side-effects from the donor cells. We are committed to advancing this clinical program on behalf of patients facing steroid-refractory aGvHD.” Patients with aGvHD who do not respond to standard steroid treatments have limited therapeutic options and face severe inflammation, tissue damage and a high risk of mortality. Each year, approximately 4,000 patients develop steroid-refractory aGvHD within the U.S., EU and Japan. RLS-0071, an investigational medicine based on the Company’s novel EPICC peptide platform, seeks to address this unmet medical need by capitalizing on its unique dual-targeting MOA to modulate both the complement and innate inflammatory pathways, offering a new hope for patients with this devastating condition. RLS-0071 was recently granted Orphan Drug Designation and Fast Track Designation for the treatment of steroid-refractory aGvHD by the U.S. Food and Drug Administration (FDA). The Company is also currently conducting Phase 2 clinical trials of RLS-0071 in newborns with hypoxic ischemic encephalopathy (HIE) ( NCT05778188 ) and hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease (AE-COPD) ( NCT06175065 ). About the Study The Phase 2 study ( NCT06343792 ) is an open-label, prospective, dose-escalation trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, dosing and efficacy of RLS-0071 for the secondary treatment of acute graft-versus-host disease (aGvHD) in hospitalized patients who are steroid-refractory. Participants will receive RLS-0071 at their assigned dose level(s) for 7 or 14 days as either a monotherapy or concurrent with the standard-of-care treatment, ruxolitinib. Primary outcomes measures include safety and overall response rate. About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a clinical mid-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address life threatening rare and acute inflammatory diseases. The Company’s EPICC peptide platform is based on discoveries related to the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis by inhibiting components of the innate immune system – a trait unique among viruses. By inhibiting activation of the complement cascade and two key neutrophil-driven mechanisms of inflammation and host tissue destruction - myeloperoxidase (MPO) and neutrophil extracellular traps (NETs), ReAlta’s therapeutic peptides leverage the dual-targeting mechanisms of this human enteric virus – and its millions of years of evolutionary adaptations – to modulate both complement and innate inflammatory pathways. The Company’s pipeline is led by RLS-0071, which has received both Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation by the European Medicines Agency, for the treatment of hypoxic ischemic encephalopathy (HIE), a devastating disease that causes brain damage in oxygen-deprived newborns and is a leading cause of cerebral palsy; Orphan Drug Designation and Fast Track Designation by the FDA for the treatment of acute graft-versus-host disease (aGvHD), a disease associated with bone marrow and stem cell transplants whereby transplanted white blood cells attack the new host in an inflammatory response; and IND clearance by the FDA for the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD), an inflammatory lung disease characterized by progressive airflow limitations and tissue destruction that makes it challenging for patients to breathe. The company launched in 2018 and is located in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit www.realtalifesciences.com .