Virginia-based clinical biotech company ReAlta Life Sciences has received clearance from the U.S. Food and Drug Administration for an Investigational New Drug (IND) application for a phase 2 clinical trial of a treatment for COPD patients with acute exacerbations.
The treatment — RLS-0071 — is the company’s lead dual-action complement and innate inflammatory inhibitor peptide in development for acute exacerbation COPD and other rare and acute inflammatory diseases.
"Patients with 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,” said ReAlta CEO Ulrich Thienel, MD, PhD. “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. 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 a placebo as an add-on to their 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 the placeb, and clinical progression and resolution.
