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.
“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,” says EpiEndo’s Chief Medical Officer, Ginny Norris.
A 12-week double-blinded, randomized, placebo-controlled study
The study will be conducted in up to 60 adults diagnosed with COPD across 6 clinics in the UK and Germany. 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.
Photo of team EpiEndo