Start of follow-on clinical LPS challenge study with glasmacinal (EP395)

REYKJAVIK, ICELAND – 26 March 2025 – EpiEndo Pharmaceuticals (‘EpiEndo’ or the ‘Company’), a clinical-stage biopharmaceutical company committed to developing oral drugs for chronic respiratory diseases, focusing on the high unmet need of COPD patients, has started a second clinical LPS challenge study with lead asset, glasmacinal (EP395).

In the first LPS study (NCT05516316), EpiEndo showed that glasmacinal significantly enhances the host defense response to the inhaled challenge. This follow-on LPS challenge study aims to explore the effects of lower doses of glasmacinal than used in the previous study. This is important for understanding the effects of lower doses of glasmacinal and for selecting doses to progress into later clinical development. This study will also add further mechanistic understanding of glasmacinal as additional biomarkers are included in this study.

The study is being conducted at the Fraunhofer Institute for Toxicology and Experimental Medicine in Germany, under Principal Investigator Prof. Dr Jens Hohlfeld, Division Director of Airway Research. For more information, please see Clinicaltrials.gov, study number NCT06677918.

EpiEndo’s CMO, Dr Ginny Norris, commented:

“The results of this study will be key to the further development of glasmacinal by supporting the selection of doses to be included in a large exacerbation reduction study in patients with COPD.”

“Through our clinical and pre-clinical work, we continue to build a better mechanistic understanding of glasmacinal and its potential as an effective treatment for COPD”.

-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 treating chronic respiratory diseases. It was founded on the knowledge that macrolide antibiotics such as azithromycin reduce exacerbations of COPD and other respiratory diseases - effects beyond their antibacterial properties.

This led EpiEndo to develop a new class of orally available macrolides, with reduced antimicrobial resistance (AMR) potential, known as ‘Barriolides™’. These show promise as first-in-class therapeutics for chronic respiratory diseases. EpiEndo’s lead asset, glasmacinal (EP395), was the first Barriolide™ to enter clinical trials for chronic obstructive pulmonary disease (COPD).

Glasmacinal aims to be the first on-market oral, anti-inflammatory drug which also enhances the host defense response to inhaled pathogens and has the potential to be an impactful treatment option for COPD patients beyond current standard treatment with inhaled bronchodilators and corticosteroids. 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.