ERJ Open Research article reports first clinical trial of glasmacinal (EP395) in COPD patients
- Glasmacinal, a novel macrolide, was well tolerated and reduced neutrophilic inflammation in COPD patients.
- Glasmacinal had no detectable impact on the lung microbiome supporting the in vitro findings of negligible anti-microbial activity.
REYKJAVIK, ICELAND – 8 December 2025 – EpiEndo Pharmaceuticals (‘EpiEndo’ or the ‘Company’) is developing glasmacinal, an orally available macrolide with reduced antimicrobial resistance (AMR) potential. It is the first in a new class of oral anti-inflammatory drugs that enhance the host defence response to inhaled pathogens.
The article, A randomised controlled trial of EP395, a novel anti-inflammatory macrolide, in stable COPD patients, was authored by the clinical trial investigators and research partners (PD Dr. med. Henrik Watz, PD Dr med. Stephanie Korn, Dr. med. Oliver Kornmann, Prof Dave Singh, Prof Tom Wilkinson, Prof Karl Staples, and Dr Jodie Ackland), and EpiEndo’s Chief Medical Officer, Dr Ginny Norris and Director Clinical Operations & Sciences, Dr Kate Hanrott.
The article reports a randomised, double-blind placebo-controlled trial in which stable COPD patients received 12 weeks’ treatment with glasmacinal. Glasmacinal was well-tolerated and reduced neutrophilic inflammation in sputum. Glasmacinal had no detectable impact on the lung microbiome, supporting the in vitro findings that glasmacinal has minimal antimicrobial activity and therefore reduced AMR potential when taken chronically. Additionally, more patients who took glasmacinal had clinically meaningful improvements in symptoms (St George’s Respiratory Questionnaire) versus placebo treated patients.
PD Dr. med. Henrik Watz, Chief Investigator, Velocity Clinical Research commented:
“I am happy to see these important data becoming available to the scientific community. The data are encouraging and show 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.”
Dr Ginny Norris, Chief Medical Officer at EpiEndo Pharmaceuticals added:
“The data reported support the continued development of EP395 as a potential chronic treatment for reducing exacerbations of COPD. We are currently planning an exacerbation reduction trial in COPD patients who continue to experience exacerbations despite receiving standard of care therapy.”
-ENDS-
Contact:
EpiEndo Pharmaceuticals:
Maria Bech, CEO
+354 454 0090
Vigo Consulting (media relations):
Rozi Morris
+44 20 7390 0230
epiendo@vigoconsulting.com
About EpiEndo Pharmaceuticals (www.epiendo.com)
EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to chronic respiratory diseases that focuses on the role of epithelial function in various inflammatory disorders.
EpiEndo’s new class of orally available macrolides, with reduced antimicrobial resistance (AMR) potential, known as ‘Barriolides™’, show promise as first-in-class therapeutics for chronic respiratory diseases as well as other inflammatory indications. EpiEndo’s lead asset, glasmacinal, was the first Barriolide™ to enter clinical trials, for chronic obstructive pulmonary disease (COPD).
Glasmacinal aims to be a first on-market oral treatment which is anti-inflammatory and enhances the host defense response to inhaled pathogens such as viruses, bacteria & pollution. Therefore, glasmacinal has the potential to become an impactful treatment in reducing exacerbations in patients with COPD.
According to the WHO, COPD is the third leading cause of death globally, and the global economic burden of COPD is projected to cost $4.8 trillion by 2030.
