ReAlta Life Sciences announced it will present new clinical data from its hypoxic ischemic encephalopathy (HIE) program at the upcoming Pediatric Academic Societies (PAS) Annual Meeting in Honolulu, Hawaii, scheduled for April 24-28, 2025. The clinical-stage biopharmaceutical company will showcase findings from its ongoing Phase 2 STAR trial investigating RLS-0071 (pegtarazimod) in newborns with moderate to severe HIE.
HIE is a serious condition resulting from oxygen deprivation during birth that can lead to significant brain damage and high mortality rates in newborns. Currently, therapeutic hypothermia is the standard of care, but additional neuroprotective strategies are urgently needed to improve outcomes.
The company will present two posters featuring important clinical data from the STAR trial (NCT05778188), which is currently enrolling patients at 13 Neonatal Intensive Care Units (NICUs) across the United States. The trial is designed as a two-stage, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of RLS-0071 in newborns with HIE who are undergoing therapeutic hypothermia.
Key Presentations on Inflammatory Biomarkers and Pharmacokinetics
The first poster presentation, titled "Early Granulocyte Inflammatory Biomarkers in Newborn Babies with Moderate or Severe Hypoxic Ischemic Encephalopathy," will be presented on Friday, April 25, 2025, from 5:30 to 7:45 PM HST during the Neonatal Neurology 3 session. This presentation will focus on inflammatory biomarkers associated with HIE, providing insights into the underlying pathophysiology of the condition.
The second poster, "Pharmacokinetics of RLS-0071, a Novel Anti-Inflammatory Peptide, in Newborns With Moderate or Severe Hypoxic Ischemic Encephalopathy," will be presented on Sunday, April 27, 2025, from 8:30 to 10:45 AM HST during the Neonatal Neurology 4 session. This presentation will detail the pharmacokinetic profile of RLS-0071 in the vulnerable neonatal population.
RLS-0071: A Novel Dual-Targeting Anti-Inflammatory Approach
RLS-0071 (pegtarazimod) represents ReAlta's innovative approach to addressing inflammatory conditions. The peptide is derived from the company's EPICC platform, which leverages discoveries from the human astrovirus (HAstV-1) that uniquely inhibits components of the innate immune system.
The therapeutic peptide employs a dual-targeting mechanism to modulate both complement and innate inflammatory pathways. Specifically, it inhibits complement cascade activation and two key neutrophil-driven mechanisms: myeloperoxidase (MPO) and neutrophil extracellular traps (NETs). This comprehensive approach to inflammation control may provide significant advantages in treating HIE, where both pathways contribute to secondary brain injury.
Regulatory Recognition and Development Pipeline
The U.S. Food and Drug Administration (FDA) has granted RLS-0071 both Orphan Drug Designation and Fast Track Designation for HIE, recognizing the significant unmet medical need in this area. The European Medicines Agency has also granted Orphan Drug Designation for the compound in HIE.
Beyond HIE, ReAlta is developing RLS-0071 for other inflammatory conditions. The compound has received FDA Orphan Drug and Fast Track Designations for acute graft-versus-host disease (aGvHD) associated with bone marrow and stem cell transplants. Additionally, the FDA has cleared an Investigational New Drug (IND) application for RLS-0071 in acute exacerbations of chronic obstructive pulmonary disease (COPD).
Significance for Neonatal Care
"The data being presented at PAS 2025 represents an important step forward in our understanding of how to potentially address the inflammatory cascade that contributes to brain injury in newborns with HIE," said John Rickman, Chief Financial Officer at ReAlta Life Sciences. "We are committed to developing innovative therapies that may help improve outcomes for these vulnerable patients."
The STAR trial is particularly significant as it evaluates a novel therapeutic approach that could potentially be used in conjunction with therapeutic hypothermia, the current standard of care. If successful, RLS-0071 could represent the first pharmacological intervention specifically designed to address the inflammatory component of HIE.
Founded in 2018, ReAlta Life Sciences operates in Norfolk, Virginia and Aguadilla, Puerto Rico. The company continues to advance its pipeline of anti-inflammatory therapies based on its proprietary EPICC peptide platform, with a focus on rare and acute inflammatory diseases with high unmet medical needs.
