Glasmacinal, a novel macrolide treatment for COPD, has received its first clinical trial in COPD patients. The study, “A Randomized Controlled Trial of EP395, a Novel Anti-inflammatory Macrolide, in Stable COPD Patients,” was published in ERJ Open Research.
According to a news release, glasmacinal is being developed by EpiEndo Pharmaceuticals as an orally available treatment with the potential for reduced antimicrobial resistance. It is the first in a new class of oral anti-inflammatory drugs that enhance the defense response of the host to inhaled pathogens.
The trial was a randomized, double-blind, placebo-controlled study in which stable COPD patients received 12 weeks of treatment with glasmacinal. Researchers reported the drug was well-tolerated and reduced neutrophilic inflammation in sputum. It had no detectable impact on the lung microbiome, supporting earlier findings that glasmacinal has minimal antimicrobial activity. This means it reduced antimicrobial resistance potential when taken regularly. Most of the patients who took glasmacinal had clinically meaningful improvements in symptoms versus those who took the placebo.
Henrik Walz, MD, chief investigator at Velocity Clinical Research — the firm that conducted the study — said it was important for this data to become available to the scientific community.
“The data is encouraging and shows that glasmacinal has the potential to become an important treatment option for patients with frequent exacerbations, especially those with neutrophilic inflammation for whom there are currently limited treatment options,” he said.
The company plans to do more trials in the future. Ginny Norris, MD, chief medical officer at EpiEndo Pharmaceuticals, said the company is currently planning an exacerbation reduction trial in patients who continue to experience exacerbations despite receiving standard of care therapy.
