Clinical and Pre-Clinical Data on the Novel Barriolide, EP395 (glasmacinal), Published in Three Articles in Pulmonary Pharmacology and Therapeutics

EpiEndo Pharmaceuticals (‘EpiEndo’ or the ‘Company’), a clinical-stage biopharmaceutical company developing a new class of oral anti-inflammatory drugs which enhance the host defence response to inhaled pathogens, has had three articles published in peer-reviewed journal, Pulmonary Pharmacology and Therapeutics.

These publications describe the potential for EpiEndo’s lead asset EP395, also known as ‘glasmacinal’, to be of therapeutic benefit in the treatment of COPD and support its continued clinical development. The article “Effect of EP395, a novel anti-inflammatory macrolide, in an inhaled lipopolysaccharide challenge model in healthy volunteers: a randomised controlled trial” reports that EP395 enhances the host defence response to inhaled LPS whilst reducing pro-inflammatory mediators. The paper was co-authored with investigators from Fraunhofer Institute for Toxicology and Experimental Medicine who conducted the study.

The second article, “Effects of EP395, a novel macrolide, on acute neutrophilic airway inflammation” describes preclinical data that demonstrate EP395 has comparable inhibitory effects on acute neutrophilic airway inflammation to azithromycin, which is used chronically off-label for its immunomodulatory properties to reduce COPD exacerbations.

Finally, “A novel macrolide, EP395, with reduced antibacterial activity and an enhancing effect on respiratory epithelial barrier” reports that EP395 has negligible antibiotic activity and enhances the barrier function of the respiratory epithelium.

Maria Bech, CEO of EpiEndo Pharmaceticals commented:

“It is great to see the publication of this clinical and pre-clinical research in a peer-reviewed journal, highlighting the efficacy we are seeing with glasmacinal in neutrophilic inflammation.

“The anti-inflammatory effects of glasmacinal are comparable to those seen with azithromycin preclinically, but without anti-microbial activity. The clinical LPS study shows that EP395 enhances the host defence response to inhaled challenge, supporting our hypothesis that glasmacinal could be effective in reducing exacerbations in COPD but without developing anti-microbial resistance.

“We continue to develop glasmacinal as a potential new oral treatment option for COPD patients, aiming to bring additional therapeutic options to patients with chronic respiratory diseases.”

Professor Clive Page, Emeritus Professor of Pharmacology, King’s College London and Chairman of EpiEndo Pharmaceutical’s Scientific Advisory Board added:

“These exciting new data demonstrate glasmacinal’s effect on neutrophilic inflammation both in a clinical study and in established non-clinical models of airways disease. These novel findings, coupled with data presented at ERS in 2024 on EP395’s anti-inflammatory effect on eosinophilic inflammation (caused by allergens), demonstrate the broad anti-inflammatory activity of this drug that has the potential to provide a novel, groundbreaking approach to treat patients with COPD, irrespective of their type of inflammation.”

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250611187825/en/