In this week’s episode of the Xtalks Life Science Podcast, host Soumya Shashikumar, Senior Life Sciences Journalist at Xtalks, spoke with Dr. Kia Moteshari, President and Chief Operating Officer of ReAlta Life Sciences, about the biology of hypoxic-ischemic encephalopathy (HIE) and the scientific, clinical and regulatory considerations shaping treatment development.
HIE is a serious neonatal brain injury caused by insufficient oxygen and blood flow to the brain around the time of birth. Dr. Moteshari explained that clinicians can often recognize the condition soon after delivery through signs such as low Apgar scores and abnormal blood gas results, but preventing lasting brain injury remains difficult.
Therapeutic hypothermia, or controlled cooling, is the current standard of care for newborns with moderate to severe HIE. Cooling can help limit inflammation and secondary injury, but there are no approved drug therapies for HIE. Severe HIE can be fatal, while children who survive may later develop neurodevelopmental complications such as cerebral palsy or epilepsy.
The discussion explored reperfusion injury, which can occur when blood flow returns to the brain after oxygen deprivation. This process may trigger a secondary inflammatory cascade that can cause further brain injury.
Dr. Moteshari explained why addressing a single inflammatory mechanism may not be enough. ReAlta’s investigational therapy is intended to target both complement- and neutrophil-driven inflammation alongside therapeutic hypothermia.
For neonatal HIE trials, the treatment window can be only a few hours. Clinicians have limited time to identify eligible newborns, explain the research and obtain informed consent from families facing an acute medical crisis. The process may be further complicated when a baby is transferred to a neonatal intensive care unit and the parents are temporarily separated.
Newborns have also not yet developed the motor and cognitive abilities used to evaluate treatment effects in older patients. An MRI may offer an earlier way to assess brain injury, followed by longer-term monitoring of developmental outcomes.
Dr. Moteshari also outlined why clearer regulatory pathways and greater investment may be needed to strengthen the limited HIE drug-development pipeline.
Tune in to learn about HIE pathophysiology, the narrow intervention window in neonatal trials and efforts to reduce brain injury beyond cooling alone.
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