Phase 2 trial of RLS-0071 : ReAlta’s innovative approach to treating rare newborn disease

ReAlta Life Sciences, Inc., a clinical mid-stage biotech company focusing on rare life-threatening diseases, has announced the commencement of dosing in a Phase 2 clinical trial for RLS-0071. The investigational new drug aims to evaluate safety and efficacy for treating hypoxic ischemic encephalopathy (HIE) in newborns, offering a new avenue for addressing an urgent medical need.

ReAlta Life Sciences‘ CEO, Ulrich Thienel, expressed the significance of this step, saying, “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. HIE is a disease with incredible unmet need, profoundly affecting the lives of thousands of children born each year in the U.S. and many more across the world. 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 Phase 2 trial, referred to as the STAR study, is structured as a two-stage, randomized, double-blind, placebo-controlled investigation. It is designed to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of RLS-0071 in newborns suffering from moderate or severe hypoxic-ischemic encephalopathy. Stage 1 of the trial will involve approximately 40 participants receiving either ascending doses of RLS-0071 or a placebo, in addition to standard care treatment like hypothermia for 72 hours. Upon completion of Stage 1, participants will transition to Stage 2 for long-term observation up to 24 months of age.

The primary focus of the study is on safety, with key secondary endpoints including assessments of mortality, seizure burden, and neurocognitive development.

The initiation of this Phase 2 clinical trial underscores ReAlta Life Sciences’ commitment to leveraging the power of the immune system and the dual action complement inhibitor and innate anti-inflammatory peptide of RLS-0071 for the treatment of hypoxic ischemic encephalopathy, acute GvHD, and acute COPD. It represents a significant milestone in the journey to providing new treatment solutions for serious health conditions affecting newborns, not only in the United States but also globally.