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 featuring new analysis of clinical data from its acute exacerbations of chronic obstructive pulmonary disease (AE-COPD) program at the American Thoracic Society (ATS) 2025 International Conference, taking place May 18-21, 2025 in San Francisco.

The new findings, presented today in a poster titled “Effect of RLS-0071 on Airway Neutrophilia Following Inhaled Endotoxin Challenge Assessed by ChipCytometry,” were from additional analysis of samples from ReAlta’s previously reported Phase 1b study of RLS-0071 (pegtarazimod). Pegtarazimod is a 15-amino-acid peptide that uniquely targets both humoral and cellular inflammation. The analysis, conducted using ChipCytometry, extends the original proof-of-mechanism findings regarding inhibition of lung neutrophils and inflammatory cytokines, and reveals cellular-level mechanisms. Airway neutrophilia is associated with several lung diseases, including acute exacerbations of COPD and severe asthma, and related lung damage is a result of neutrophil-mediated release of toxic myeloperoxidase (MPO) and neutrophil elastase (NE). In this ChipCytometry analysis, pegtarazimod prevented lipopolysaccharide (LPS)-driven increases in neutrophil activation markers (CD89, CD11a, CD11b) as well as intracellular levels of MPO and NE.

In ReAlta’s Phase 1b study, healthy participants received inhaled LPS to induce temporary neutrophil-mediated inflammation in the lungs, followed by intravenous administration of pegtarazimod at different dose levels. Pegtarazimod demonstrated powerful inhibition of neutrophil migration into the lungs by half (~50%), with significant reductions in key inflammatory markers including MPO and NE, and pro-inflammatory cytokines IL-1β and IL-8.

“These new data further reinforce pegtarazimod's potential to address neutrophil-driven inflammation in the lungs by meaningfully reducing detrimental neutrophil activation,” said Kenji M. Cunnion, MD, MPH, Chief Medical Officer at ReAlta. “We look forward to completing our Phase 2 trial in patients with AE-COPD (NCT06175065) later this year and exploring opportunities for our novel dual-targeting peptide platform to deliver effective new therapies for respiratory diseases.”

Prof. Dr. Jens M. Hohlfeld, Division Director of Airway Research at the Fraunhofer Institute for Toxicology and Experimental Medicine in Hannover, Germany and lead investigator for the study, commented, “ChipCytometry analysis offers various advantages over conventional flow cytometry and differential cell counts that allowed us to visualize how pegtarazimod impacts neutrophil activation markers and intracellular components, which had not been directly observable in our previous analyses. These new insights into pegtarazimod's cellular-level mechanisms of action strengthen the scientific foundation for its development and will inform other upcoming clinical trials in patients with neutrophil-driven inflammatory conditions.”

About ReAlta Life Sciences

ReAlta Life Sciences, Inc. is a clinical mid-stage biopharmaceutical company dedicated to addressing life threatening rare and acute inflammatory diseases by rebalancing the inflammatory response. The Company’s EPICC peptide platform leverages discoveries from the human astrovirus (HAstV-1), which uniquely inhibits components of the innate immune system. ReAlta’s therapeutic peptides employ the dual-targeting mechanisms of HAstV-1 to modulate both complement and innate inflammatory pathways by inhibiting complement cascade activation and two key neutrophil-driven mechanisms: myeloperoxidase (MPO) and neutrophil extracellular traps (NETs). The Company’s lead candidate, RLS-0071 (pegtarazimod), has received FDA Orphan Drug Designation and Fast Track Designations for hypoxic ischemic encephalopathy (HIE), a devastating disease that causes brain damage and high mortality in oxygen-deprived newborns; Orphan Drug Designation by the European Medicines Agency for HIE; FDA Orphan Drug and Fast Track Designations for acute graft-versus-host disease (aGvHD) associated with bone marrow and stem cell transplants; and FDA IND clearance for acute exacerbations of chronic obstructive pulmonary disease (COPD). Founded in 2018, ReAlta operates in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit www.realtalifesciences.com.

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