FDA clears Phase 2 trial of RLS-0071 for COPD exacerbations

ReAlta therapy candidate aims to ease inflammation in patients

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Food and Drug Administration (FDA) has approved ReAlta Life Sciences’ request to launch a Phase 2 clinical trial testing its experimental anti-inflammatory therapy RLS-0071 in people with chronic obstructive pulmonary disease (COPD) who are experiencing disease exacerbations.

Exacerbations, or disease flare-ups, may occur several times per year — particularly in colder weather — in some patients with the inflammatory disease.

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

“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,” Thienel added.

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Trial will test therapy in patients hospitalized with COPD exacerbations

The upcoming trial will enroll people with COPD who are hospitalized due to an acute exacerbation. Participants will be randomly assigned to receive either RLS-0071 or a placebo, in addition to standard-of-care treatment.

The trial’s main goal will be to assess the safety of the experimental therapy. Markers of inflammation and the body’s response to RLS-0071 also will be assessed.

ReAlta did not specify when the trial is expected to start or where it will be conducted.

Administered directly into the bloodstream, RLS-0071 is designed to reduce inflammation through two simultaneous mechanisms. First, it blocks the activity of myeloperoxidase or MPO, an enzyme that’s critical to the activation of a type of immune cell called neutrophils.

These cells drive inflammation by making a protein called neutrophil elastase and undergoing NETosis, in which they release sticky web-like nets made of DNA and other molecules to trap and kill microbes.

RLS-0071 also suppresses the activation of the complement cascade, a group of immune proteins in the blood and other bodily fluids that trigger a potent inflammatory response when activated by potential threats. The therapy specifically targets the C1 complement protein.

Both neutrophils and the complement cascade are believed to play key roles in COPD exacerbations, according to ReAlta.

“Once triggered, an acute exacerbation of COPD is driven by neutrophil effectors including myeloperoxidase, neutrophil elastase, NETosis, and complement activation, and this underlying [disease-associated mechanism] leads to poorer quality of life for patients and an increased risk of death,” Thienel said.

Data from previous Phase 1 trials in healthy adult volunteers confirmed RLS-0071’s anti-inflammatory effects.

Once triggered, an acute exacerbation of COPD is driven by neutrophil effectors … and complement activation, and this underlying [disease-associated mechanism] leads to poorer quality of life for patients and an increased risk of death.


In a Canada-based Phase 1 trial (NCT05298787), single and multiple doses of the therapy were shown to be generally safe and to effectively target MPO and the complement pathway.

Importantly, this results was seen in a healthy volunteer with mildly high MPO levels, further supporting RLS-0071’s potential to treat conditions characterized by MPO-related responses.

In another Phase 1 study (NCT05351671), in which healthy participants in Germany were exposed to a trigger of lung inflammation, the therapy was found to be superior to a placebo at lowering the number of neutrophils and levels of MPO and neutrophil elastase in lung mucus samples.

Overall, these early trial findings support further studies to assess RLS-0071’s safety and efficacy for treating neutrophil-related diseases, including those affecting the lungs.

“This FDA clearance marks an important new milestone for ReAlta as we explore the potential of RLS-0071 across multiple therapeutic areas,” Thienel said.

The company also is developing RLS-0071 as a potential treatment for other inflammatory conditions such as acute graft-versus-host disease and hypoxic-ischemic encephalopathy.