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14 Nov 2022

Commencement of Ph2a trial for EP395 in COPD patients

EpiEndo Pharmaceuticals has received regulatory approval to commence a Phase 2a clinical trial with lead molecule EP395 in COPD (Chronic Obstructive Pulmonary Disease) patients.

EP395 is an orally available macrolide or ‘Barriolide™,’ with reduced antimicrobial resistance potential, which aims to address the unmet medical need for a treatment for COPD.

The study will be conducted in up to 60 adults diagnosed with COPD across 6 clinics in the UK and Germany. The Principal Investigator of the study is Professor Dave Singh, Professor of Respiratory Pharmacology at the University of Manchester and Medical Director of the Medicines Evaluation Unit. The study is a 12-week double-blinded, randomized, placebo-controlled study. The study will assess the safety and tolerability of EP395 in COPD patients, as well as assessing the effect of EP395 on inflammatory and potential barrier enhancing biomarkers in the lung.

The results of the study are expected in H2 2023 and will provide key data on EP395 in a COPD population. For more information on the study, see (NCT05572333).

EpiEndo takes a novel approach to drug development for chronic respiratory diseases, focusing on using its Barriolide™ compounds to enhance the integrity of the epithelial cell layer in the lung to reduce disease-caused inflammation.

There are currently limited treatment options available for the treatment of COPD and there is a high unmet need for new treatments. COPD is the third leading cause of death globally, with the global cost of COPD estimated to rise to $4.8 trillion by 2030*.

Commenting on the study, EpiEndo’s Chief Medical Officer, Ginny Norris, said:

This is the first time that EP395 will be tested in COPD patients, and we are looking forward to the invaluable data that this study will provide. The information gained from this study, together with the LPS challenge study, will provide a strong data set to support the further development of EP395."

Principal Investigator, Prof Dave Singh, added:

There is a large unmet need for alternative, safe and effective treatments for COPD and I am pleased to be involved in the development of EP395 and a study that will provide vital insights into the potential for this new class of therapeutic.


*The Global Economic Burden of Noncommunicable Diseases. Geneva: World Economic Forum, 2011