First patient dosed in phase 2 study of hypoxic ischemic encephalopathy drug

A Virginia-based biotech company has announced dosing of the first patient in a phase 2 clinical trial examining safety and efficacy of its investigational anti-inflammatory peptide, RLS-0071, to treat hypoxic ischemic encephalopathy in newborns.

According to a release from ReAlta Life Sciences, hypoxic ischemic encephalopathy, or HIE, is also known as birth asphyxia and affects newborns via abrupt, unexpected loss of oxygenation due to placental rupture, umbilical cord problems or other factors. The disease often results in death or moderate-to-severe cognitive and physical disabilities.

“This is a special day for ReAlta and the patients we hope to serve, as we announce the dosing of the first patient in the first human efficacy trial in our company’s history,” ReAlta CEO Ulrich Thienel, MD, PhD, said in the release. “I am proud of the work of our team and thankful for the support from clinicians and colleagues in the patient community who have enabled this important milestone.”

The STAR study will be a two-stage, randomized, double-blind, placebo controlled, multiple-ascending dose trial for the novel therapeutic in newborns with moderate or severe hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia with long-term follow up.

In stage 1, approximately 40 participants will receive either ascending doses of RLS-0071 or placebo along with standard of care, including hypothermia, for 72 hours. Stage 2 involves long-term observation of patients for up to 24 months.

“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,” ReAlta Chief Medical Officer Kenji Cunnion, MD, MPH, said in the release.

ReAlta additionally revealed that RLS-0071 is currently being developed to treat acute graft vs. host disease and acute chronic obstructive pulmonary disease.