ReAlta Life Sciences (“ReAlta”), Inc., a clinical mid-stage biotech company dedicated to addressing life-threatening rare diseases by harnessing the power of the immune system, announced dosing of the first patient in a Phase 2 clinical trial evaluating the safety and efficacy of RLS-0071 for the treatment of hypoxic ischemic encephalopathy (HIE) in newborns. RLS-0071, an investigational new drug, is the Company’s lead dual action complement inhibitor and innate anti-inflammatory peptide in development for the treatment of HIE, acute GvHD and acute COPD.
“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,” said ReAlta Chief Medical Officer Kenji Cunnion, MD, MPH. “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.”
Ulrich Thienel, MD, Ph.D., ReAlta Chief Executive Officer said, “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 clinical trial is a two-stage, randomized, double-blind, placebo controlled, multiple-ascending dose study to evaluate the Safety, Tolerability, pharmAcokinetics, and preliminary efficacy of RLS-0071 in newboRns with moderate or severe hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia with long-term follow up (STAR). In Stage 1, approximately 40 participants will receive either ascending doses of RLS-0071 or placebo in addition to standard of care treatment, including hypothermia for 72 hours. After completion of Stage 1, participants will transition to Stage 2 of the study for long-term observation out to 24 months of age. The primary endpoint of the study is safety. Key secondary endpoints include measures of mortality, seizure burden, and neurocognitive development. For more information about the Phase 2 STAR study, visit https://www.clinicaltrials.gov (NCT05778188).
HIE, also known as birth asphyxia, is a rare disease that affects newborns suffering an abrupt, unexpected loss of oxygenation due to placental rupture, umbilical cord problems, or other factors. The initial loss of oxygen and the dysregulated inflammatory process that follows causes damage to the brain and other organs. This acute disease often results in death or moderate-to-severe cognitive and physical disability, with life-long impacts on both the newborn and the newborn’s family.