Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

This is a randomized, double-blind, placebo controlled trial in hospitalized participants with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) to evaluate the safety, tolerability, preliminary efficacy, PK, and PD of RLS-0071 compared to Placebo in the treatment of AECOPD. The dosing regimen will be 3 times a day for at least 3 days and up to 5 days total if still hospitalized. Participants will be followed for efficacy and safety for 30 and 60 days after the final dose. RLS-0071 or Placebo will be given as add-on therapy to SOC management for acute exacerbations of COPD.

Inclusion criteria

• Hospitalized participants with a prior diagnosis of COPD including spirometry within the prior year documenting a postbronchodilator FEV1/FVC ≤ 0.7 and an FEV1

≤ 80%, and a clinician identified admitting diagnosis of AECOPD: acute increase in dyspnea, sputum volume or purulence - without other attributable cause.

• Participants must have a moderate exacerbation of COPD according to the Rome guidelines
• ≥ 10 pack-years smoking history.

Exclusion criteria

• Endotracheal intubation or mechanical ventilation.
• Participants with severe exacerbation of COPD according to the Rome guidelines
• Participants with signs and symptoms consistent with an alternative diagnosis for worsening of pulmonary status
• Interstitial lung disease.
• Current or prior history of asthma.
• Known hypersensitivity, allergy, or reaction to polyethylene glycol (PEG)
• Preexisting autoimmune disease: History of autoimmune disease and/or use of chronic steroids of >10mg/d (prednisone or equivalent) for more than 14 days prior to enrollment
• Current renal dialysis or renal dialysis planned or anticipated in the next 7 days.
• Has confounding medical conditions, including:

• diabetic coma,
• uncontrolled New York Heart Association Class IV congestive heart failure,
• uncontrolled angina,
• stroke or transient ischemic attack (TIA) within 4 weeks before study entry,
• clinically significant arrhythmias not controlled by medication, or
• idiopathic pulmonary fibrosis,
• Has a weight >120 kg at Screening.
• Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.
• Has systemic immunosuppression/immune deficiency