ReAlta Life Sciences Announces Dosing of First Patient in Phase 2 Trial of RLS-0071 for Acute Exacerbations of Chronic Obstructive Pulmonary Disease

2024-02-21

临床2期孤儿药快速通道

NORFOLK, Va.--(BUSINESS WIRE)-- ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life-threatening diseases, today announced enrollment of the first patient in a Phase 2 clinical trial evaluating the safety and efficacy of RLS-0071, an investigational new drug based on ReAlta’s novel EPICC peptide platform, for the treatment of acute exacerbations of chronic obstructive pulmonary disease (AE-COPD) in hospitalized patients. RLS-0071 is the Company’s lead dual-targeting peptide that uniquely inhibits both complement and neutrophil-associated inflammation and is currently in development for the treatment for hypoxic ischemic encephalopathy, acute graft-versus-host disease, and other rare and acute inflammatory diseases. “The novel, dual mechanism-of-action of RLS-0071 that enables the rapid inhibition of both complement activation and neutrophil effectors (including myeloperoxidase, neutrophil elastase, and NETosis) holds great promise to address the fundamental drivers of the acute exacerbations that are a pervasive threat to COPD patients,” said ReAlta Chief Medical Officer Kenji Cunnion, MD, MPH. “With few effective options available today to address acute exacerbations, this study is an important step forward in developing an effective therapy for patients with AE-COPD.” "With two Phase 2 trials now actively enrolling patients, ReAlta today reached another important milestone as we explore the potential for RLS-0071 across multiple therapeutic areas," said ReAlta CEO Ulrich Thienel, MD, Ph.D. "AE-COPD is a disease with significant unmet need, threatening the lives and well-being of millions across the world, and burdening our healthcare systems with substantial economic costs. We believe RLS-0071 can have a significant role in addressing these problems." The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled trial to evaluate safety, pharmacokinetics and pharmacokinetic-pharmacodynamic relationships of RLS-0071 in patients with acute exacerbations of chronic obstructive pulmonary disease. Approximately 24 hospitalized patients will receive doses of either RLS-0071 or placebo in addition to standard of care treatment for up to five days. The primary endpoint of the study is safety. Key secondary endpoints include biomarkers of inflammation, physiological response to RLS-0071 compared to placebo, as well as clinical progression and resolution. For more information about the study, please visit (NCT06175065). About Acute Exacerbations of Chronic Obstructive Pulmonary Disease AE-COPD is a sudden worsening, or flare-up, of COPD respiratory symptoms including shortness of breath, wheezing, and fatigue. The onset of an acute exacerbation is typically triggered by a lung infection, or exposure to an environmental irritant such as an allergen or air pollution. Exacerbations can last for days or weeks, and can lead to hospitalization, permanent, irreversible lung damage, and death. About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life threatening acute inflammatory and rare diseases. The Company’s EPICC peptides are based on research into the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis unique among viruses by inhibiting components of the innate immune system. ReAlta’s therapeutic peptides leverage these virus-derived mechanisms to rebalance complement and inflammatory processes in the body. The company’s pipeline is led by RLS-0071, which has received IND clearance by the U.S. Food and Drug Administration (FDA) for the treatment of acute exacerbations of chronic obstructive pulmonary disease and acute graft-versus-host disease, and IND clearance, Orphan Drug Designation, and Fast Track Designation by the FDA, and Orphan Drug Designation by the European Medicines Agency, for the treatment of hypoxic-ischemic encephalopathy (HIE). The company launched in 2018 and is located in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit .