Phase 2 Trial for AE-COPD Begins with First Patient Dosing

ReAlta Life Sciences, a biotech firm focused on treating severe inflammatory diseases, has initiated a Phase 2 clinical trial for RLS-0071, its leading experimental drug. The trial aims to assess the safety and effectiveness of RLS-0071 in treating acute exacerbations of chronic obstructive pulmonary disease (AE-COPD) in hospitalized patients. RLS-0071 is a unique dual-targeting peptide that simultaneously inhibits both the complement system and neutrophil-associated inflammation, which are key in AE-COPD pathogenesis. The drug is also under development for other conditions, including hypoxic ischemic encephalopathy and acute graft-versus-host disease.
Kenji Cunnion, ReAlta's Chief Medical Officer, highlighted the drug's potential to tackle the root causes of AE-COPD exacerbations, noting the scarcity of effective treatments for this condition. The CEO, Ulrich Thienel, emphasized the significance of the trial in advancing RLS-0071's development across various therapeutic areas, particularly given the high unmet medical need for AE-COPD treatments.
The trial design involves a randomized, double-blind, placebo-controlled approach with approximately 24 patients receiving RLS-0071 or a placebo alongside standard care. The primary focus is on the drug's safety, with secondary endpoints measuring inflammation biomarkers, physiological responses, and clinical outcomes. More details on the study can be found on ClinicalTrials.gov under the identifier NCT06175065.
AE-COPD is characterized by a sudden worsening of COPD symptoms, often triggered by lung infections or environmental irritants, leading to potential hospitalization and severe health consequences. ReAlta Life Sciences, established in 2018, is leveraging research on the human astrovirus HAstV-1 to develop its EPICC peptide platform. The company's lead candidate, RLS-0071, has received regulatory clearance and designations for its targeted diseases and is part of ReAlta's mission to rebalance the body's inflammatory responses to save lives. The company operates from Norfolk, Virginia, and Aguadilla, Puerto Rico.