Regulatory approval for first patient study of first non-antibiotic macrolide
REYKJAVIK, Iceland, November 14, 2022 / B3C newswire / -- EpiEndo Pharmaceuticals (‘EpiEndo’), the clinical-stage biopharmaceutical company developing therapeutics for chronic inflammatory diseases, 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 ClinicalTrials.gov (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
About EpiEndo Pharmaceuticals
EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to inflammatory disorders that focuses on enhancement of epithelial barrier integrity as a critical pathophysiological factor underlying the etiology of a number of major diseases. Epithelial cells are a key component of the barrier that makes up human lung tissue and other organs such as the gut and skin. Compromised integrity of this barrier is implicated in the progression and non-resolution of several chronic inflammatory diseases.
EpiEndo is developing a proprietary portfolio of macrolide drugs, whilst avoiding microbial resistance, called Barriolides, with promise as first-in-class therapeutics, to address the huge global burden of chronic diseases of the lung and other organs where there is significant unmet medical need. EpiEndo’s lead drug candidate, EP395, aims to be the first on-market oral macrolide with reduced antimicrobial resistance potential, is barrier strengthening and anti-inflammatory for the treatment of COPD.
Maria Bech, CEO
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Keywords: Humans; Clinical Trials, Phase II as Topic; Chronic Disease; Pulmonary Disease, Chronic Obstructive; Macrolides; Lung; Inflammation; Anti-Inflammatory Agents; Epithelium; Epithelial Cells; Lipopolysaccharides; Biological Products; Drug Development; Pharmaceutical Preparations; Iceland
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