ReAlta Life Sciences has announced significant findings from a preclinical study published in the American Journal of Perinatology, highlighting the potential of RLS-0071 (pegtarazimod) to reduce brain inflammation in newborns with hypoxic ischemic encephalopathy (HIE). The study reveals that pegtarazimod effectively lowers levels of microglia, myeloperoxidase (MPO), and reactive oxygen species (ROS), key factors in neuroinflammation and brain damage associated with HIE.
The research builds on Phase 2 STAR trial clinical biomarker data, showing elevated MPO levels in newborns with HIE, particularly in severe cases. Pegtarazimod’s ability to decrease microglial recruitment and reduce MPO staining suggests a novel approach to mitigating the inflammatory cascade that leads to brain damage in HIE patients. This is especially relevant given the lack of pharmacological interventions currently available for HIE, with therapeutic hypothermia being the standard of care.
Dr. Kenji M. Cunnion, ReAlta’s Chief Medical Officer, emphasized the importance of these findings, noting the drug’s potential to address neuroinflammation and improve outcomes for HIE babies. The preclinical study also found that pegtarazimod treatment resulted in a 6% greater neuron density compared to hypothermia alone, underscoring its therapeutic promise.
The ongoing STAR trial (NCT05778188) is evaluating pegtarazimod’s efficacy in newborns with moderate or severe HIE undergoing therapeutic hypothermia. With FDA Orphan Drug and Fast Track Designations for HIE, pegtarazimod represents a significant advancement in the search for effective treatments for this devastating condition.
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