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

ReAlta Life Sciences announced the publication of a study in the American Journal of Perinatology, revealing that pegtarazimod (RLS-0071) significantly reduces brain inflammation in a preclinical model of hypoxic ischemic encephalopathy (HIE). The study found that pegtarazimod decreases microglial recruitment and reduces levels of neuroinflammatory factors, such as myeloperoxidase (MPO) and reactive oxygen species (ROS), which are linked to tissue damage in HIE and neurodegenerative diseases.

The findings build on Phase 2 STAR trial clinical biomarker data, showing elevated MPO levels in newborns with HIE, with higher levels in severe cases. Dr. Kenji M. Cunnion, ReAlta's Chief Medical Officer, emphasized the potential of pegtarazimod to address neuroinflammation by reducing microglial-mediated inflammation, highlighting the drug's dual-targeting peptide platform's ability to interrupt the inflammatory cascade.

In the preclinical study, pegtarazimod treatment led to a fourfold decrease in microglial recruitment and significantly reduced MPO staining, a key driver of oxidative brain damage, compared to controls. Additionally, it resulted in a 6% greater neuron density than hypothermia treatment alone, the current standard of care for HIE, while showing equivalent anti-inflammatory effects.

Dr. Zachary Vesoulis, a co-author of the study, noted pegtarazimod's potential to improve clinical outcomes for HIE babies, for whom there is currently no pharmacological intervention. The ongoing STAR trial (NCT05778188) is evaluating pegtarazimod in newborns with moderate or severe HIE undergoing therapeutic hypothermia across 13 NICUs in the United States.