ReAlta Life Sciences has enrolled the first subject in a Phase II clinical trial of its investigational drug RLS-0071, aimed at treating acute exacerbations of chronic obstructive pulmonary disease (AE-COPD).
Based on the EPICC peptide platform of the company, RLS-0071 is a dual-targeting peptide. It is designed to hinder complement and neutrophil-associated inflammation.
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The double-blind, randomised, placebo-controlled trial will assess the efficacy, pharmacokinetics, safety and pharmacokinetic-pharmacodynamic links of RLS-0071.
It will enrol nearly 24 patients hospitalised with AE-COPD to receive either the investigational drug or a placebo, alongside standard care, for a duration of up to five days.
The primary focus of the Phase II trial is to evaluate the safety of RLS-0071.
Measuring biomarkers of inflammation, the physiological response to the drug versus placebo and monitoring clinical progression and resolution in trial subjects are the key secondary endpoints of the trial.
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By GlobalDataReAlta chief medical officer Kenji Cunnion said: “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.
“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.”
Last August, the company dosed the first subject in a Phase II clinical trial of RLS-0071 to treat neonates with hypoxic-ischemic encephalopathy (HIE), also known as birth asphyxia.
This multiple-ascending dose, placebo-controlled, two-stage, randomised, double-blind study has been designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of RLS-0071 in newborns.
