ReAlta’s Pegtarazimod Demonstrates Potential in Reducing Brain Inflammation in Newborn HIE Study

ReAlta Life Sciences has announced the publication of a study in the American Journal of Perinatology, showcasing the potential of RLS-0071 (pegtarazimod) to mitigate brain inflammation in a preclinical model of hypoxic ischemic encephalopathy (HIE). The study reveals that pegtarazimod effectively reduces levels of resident microglia and neuroinflammatory factors such as myeloperoxidase (MPO) and reactive oxygen species (ROS), which are implicated in the damaging inflammatory cascade associated with HIE and neurodegenerative diseases.

The findings build upon Phase 2 STAR trial clinical biomarker data, which indicated elevated MPO levels in newborns with HIE, particularly in severe cases. Dr. Kenji M. Cunnion, ReAlta's Chief Medical Officer, emphasized the significance of these results, highlighting pegtarazimod's potential to address neuroinflammation and the company's confidence in its dual-targeting peptide platform. An interim clinical data readout is anticipated in the second half of 2025.

In the preclinical study, pegtarazimod treatment led to a fourfold decrease in microglial recruitment and significantly reduced MPO staining, a key factor in oxidative brain damage. Additionally, it resulted in a 6% greater neuron density compared to hypothermia treatment alone, the current standard of care for HIE. Dr. Zachary Vesoulis, a co-author of the study, noted the drug's potential to improve clinical outcomes for HIE babies, for whom pharmacological interventions are currently lacking.

The STAR trial, evaluating pegtarazimod in newborns with moderate or severe HIE undergoing therapeutic hypothermia, is currently enrolling patients across 13 NICUs in the United States. Pegtarazimod, ReAlta's lead therapeutic candidate, has received FDA Orphan Drug and Fast Track Designations for HIE, underscoring its potential to meet significant unmet medical needs in neurological diseases.