ReAlta Life Sciences has dosed the first patient in a Phase II clinical trial of the RLS-0071 drug to treat neonates with hypoxic-ischemic encephalopathy (HIE), also known as birth asphyxia.

The two-stage, multiple-ascending dose, placebo-controlled, randomised, double-blind study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of RLS-0071 in newboRns (STAR).

Newborns with moderate or severe HIE and undergoing therapeutic hypothermia with long-term follow-up are enrolled in the study.

Nearly 40 participants are selected for stage one and will receive either ascending doses of the drug or placebo in addition to standard of care treatment, including hypothermia for 72 hours.

In stage two, participants will be observed for the long term until they reach 24 months of age.

The trial’s primary endpoint includes safety while measuring neurocognitive development, seizure burden, and mortality are key secondary endpoints.

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ReAlta Life Sciences chief medical officer Kenji Cunnion said: “The novel, dual-targeting mechanisms of action of RLS-0071, rapidly inhibiting both the complement cascade at C1 and cellular inflammation through the inhibition of myeloperoxidase (MPO) activity and NETosis, hold great promise to address the fundamental drivers of the HIE disease process.

“This study is an important step forward in developing an effective therapy to reduce the burden of this devastating neurological disease on patients and their families.”

RLS-0071 is also in development to treat acute COPD and GvHD, in addition to the rare disease HIE that causes damage to the brain and other organs of neonates due to loss of oxygen and the dysregulated inflammatory process.

It has previously received IND clearance, and orphan drug designation from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and fast-track designation for treating HIE in newborns.