Trial of RLS-0071 for acute COPD exacerbations doses 1st patient

Infusion therapy being tested in hospitalized adults in Philadelphia

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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The first patient has been dosed in a Phase 2a clinical trial testing ReAlta Life Sciences’ RLS-0071 in adults with chronic obstructive pulmonary disease (COPD) who are experiencing acute exacerbations, or sudden symptom worsening.

The trial (NCT06175065) will evaluate the safety of RLS-0071 versus a placebo in as many as 24 hospitalized patients, ages 30 and older, who will continue to receive their standard COPD treatment. Patients are being recruited at Temple University, in Philadelphia.

The dosing announcement comes about four months after the study was cleared by the U.S. Food and Drug Administration. RLS-0071 is also being tested in a Phase 2 trial that’s enrolling newborns with hypoxic ischemic encephalopathy, or brain damage from lack of oxygen around time of birth.

“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,” Ulrich Thienel, MD, PhD, ReAlta’s CEO, said in a company press release.

In COPD, inflammation in the lungs blocks airflow, causing symptoms such as shortness of breath, wheezing, and persistent, chesty cough. Periods when symptoms suddenly worsen can occur, and are known as acute exacerbations or flares.

Acute exacerbations can be triggered by infection or exposure to an environmental irritant such as an allergen or air pollution. These flares can last for days or weeks, often leading to hospitalization and permanent lung damage.

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‘Few effective options’ for acute COPD exacerbations

While some COPD treatments may ease symptoms, there are “few effective options available today to address acute exacerbations,” said Kenji Cunnion, MD, ReAlta’s chief medical officer.

Cunnion called the Phase 2 trial “an important step forward in developing an effective therapy for patients.”

RLS-0071 is a peptide or small protein that’s designed to reduce inflammation in two ways. To start, it blocks C1, a protein key for the activation of the complement cascade, which helps the immune system mount an inflammatory response against foreign intruders. It’s administered directly into the bloodstream through infusions.

The therapy also reduces the activity of myeloperoxidase (MPO), an enzyme that helps a type of immune cells called neutrophils cast lacy structures called NETs. These trap foreign intruders and prevent them from spreading, sometimes at the expense of uncontrolled inflammation. Activated neutrophils are thought to enter the lungs and contribute to COPD symptoms.

Suppressing both complement and neutrophil activation is expected to ease inflammation and reduce the number of hospitalizations due to acute COPD exacerbations.

“The novel, dual mechanism of action of RLS-0071 that enables the rapid inhibition of both complement activation and neutrophil effectors … holds great promise to address the fundamental drivers of the acute exacerbations that are a pervasive threat,” Cunnion said.

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Phase 1 trial shows three doses halve number of neutrophils

In a Phase 1 trial (NCT05351671) involving 30 healthy people who were exposed to a lung inflammation trigger, three RLS-0071 doses were enough to reduce the number of neutrophils in the lungs by half and drop MPO levels compared with a placebo.

In the ongoing Phase 2a trial, COPD patients who have a history of smoking will be randomly assigned to either RLS-0071 or a placebo for up to five days.

RLS-0071 will be given at a dose of 10 mg/kg three times per day, for at least three days and up to five days total if patients are still hospitalized. Each infusion lasts about eight minutes.

The trial’s main goal is to monitor side effects in the two months after starting treatment. Researchers also will watch for changes in blood levels of RLS-0071 and inflammation biomarkers, as well as clinical progression and resolution.

Treating COPD acute exacerbations remains a “significant unmet need, threatening the lives and well-being of millions across the world, and burdening our healthcare systems with substantial economic costs,” Thienel said. “We believe RLS-0071 can have a significant role in addressing these problems.”