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FDA Clears ReAlta Life Sciences’ Phase 2 STAR Trial of RLS-0071 in Neonates with Hypoxic-Ischemic Encephalopathy

RLS-0071 is ReAlta’s lead dual action complement inhibitor and innate anti-inflammatory peptide in development as a treatment for hypoxic-ischemic encephalopathy and other rare diseases

Norfolk, VA, ReAlta Life Sciences (“ReAlta”), Inc., a clinical stage, rare disease company dedicated to harnessing the power of the immune system to address life threatening diseases, today announced U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for a Phase 2 clinical trial of RLS-0071 in neonates with hypoxic-ischemic encephalopathy (HIE). RLS-0071 is the Company’s lead dual action complement inhibitor and innate anti-inflammatory peptide in development as a treatment for hypoxic-ischemic encephalopathy and other rare diseases.

“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,” said Ulrich Thienel, M.D., Ph.D., ReAlta’s Chief Executive Officer. “New treatment approaches are urgently needed since the current standard of care, hypothermia, has at best marginal efficacy. RLS-0071 demonstrated neuroprotection with decreased brain infarction size, decreased neuronal death and improved long-term cognitive outcome in animal models for HIE. Results of a Phase 1 clinical trial in healthy volunteers, which will be presented at this year’s American Academy of Neurology 2022 Annual Meeting, support proceeding with the Phase 2 trial in HIE. The Phase 1 data demonstrated a very well-tolerated safety profile and confirmed target engagement.”

RLS-0071 is a 15 amino acid peptide that inhibits both humoral inflammation by blocking classical pathway complement activation and cellular inflammation by blocking the neutrophil effectors myeloperoxidase (MPO) and neutrophil extracellular traps (NETs).

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.

Read more here.

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