NORFOLK, Va.--(BUSINESS WIRE)--ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a mid-stage clinical biotech company focused on 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 patients with acute exacerbations of chronic obstructive pulmonary disease (AE-COPD). RLS-0071 is the Company’s lead dual-action complement and innate inflammatory inhibitor peptide in development for AE-COPD, acute graft-versus-host disease (aGvHD), hypoxic-ischemic encephalopathy (HIE), and other rare and acute inflammatory diseases.
“Patients with chronic obstructive pulmonary disease (COPD) face the persistent threat of hospitalization, mechanical ventilation and death from an acute exacerbation, an acute worsening of symptoms triggered by a viral or bacterial infection, or environmental irritant. Once triggered, an acute exacerbation of COPD is driven by neutrophil effectors including myeloperoxidase, neutrophil elastase, NETosis, and complement activation, and this underlying pathogenesis leads to poorer quality of life for patients and an increased risk of death. With current treatment options limited and poorly matched to the disease process, we believe RLS-0071 has the potential to fill this unmet need given its dual-targeting and rapid mechanism of action,” said ReAlta Chief Executive Officer Ulrich Thienel, MD, PhD. “This FDA clearance marks an important new milestone for ReAlta as we explore the potential of RLS-0071 across multiple therapeutic areas."
The Phase 2 clinical trial will be a randomized, double-blind, placebo-controlled trial in hospitalized patients with AE-COPD. Patients will receive either RLS-0071 or placebo as an add-on to standard of care therapy. 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.
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 viral or bacterial 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 harnessing the power of the immune system 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. For more information, please visit www.realtalifesciences.com.