ReAlta Life Sciences has obtained clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to begin the Phase II clinical trial of RLS-0071 to treat hypoxic-ischemic encephalopathy (HIE) in neonates.
The randomised, two-stage, placebo-controlled, double-blind, multiple ascending dose trial will assess the safety, tolerability, pharmacokinetics and initial efficacy of RLS-0071 for treating moderate or severe HIE in new-borns who undergo hypothermia treatment.
In the initial stage of the trial, nearly 40 subjects will be given either ascending doses of RLS-0071 or placebo, along with the standard of care therapy, including hypothermia for 72 hours.
On concluding the first stage, subjects will transition to the second stage of the trial for long-term monitoring until two years of age.
According to the data from the Phase I trial, RLS-0071 was found to possess a well-tolerated safety profile with established target engagement.
A lead dual-action complement inhibitor and innate anti-inflammatory peptide, RLS-0071 is being developed to treat HIE as well as various other rare diseases.
This 15 amino acid peptide hinders humoral and cellular inflammation by preventing classical pathway complement activation and obstructing the neutrophil effectors myeloperoxidase (MPO) and neutrophil extracellular traps (NETs), respectively.
ReAlta Life Sciences CEO Ulrich Thienel said: “HIE is the tragic consequence of brain asphyxia during birth, effecting one baby every hour in the United States and represents a major cause of infant death globally.
“RLS-0071 demonstrated neuroprotection with decreased brain infarction size, decreased neuronal death and improved long-term cognitive outcome in animal models for HIE.”
The US FDA and European Medicines Agency have previously granted Orphan Drug Designation to RLS-0071 for HIE treatment in neonates.