Regulatory approval for proof of pharmacology study for the first non-antibiotic macrolide
REYKJAVIK, Iceland, August 31, 2022 / B3C newswire / -- EpiEndo Pharmaceuticals (‘EpiEndo’), the clinical-stage biopharmaceutical company developing disease-modifying therapeutics for chronic respiratory disorders, has received regulatory and ethics approval to commence a Lipopolysaccharide (LPS) challenge clinical trial with lead molecule EP395. EP395 is an orally available macrolide or ‘Barriolide™’ with reduced antimicrobial activity which aims to address the unmet medical need for a treatment for COPD (Chronic Obstructive Pulmonary Disease).
The study will be conducted in up to 48 healthy adults at the Hannover Medical School in Germany. The Principal Investigator is Professor Jens Hohlfeld, Director of Airway Research and Aerosol Medicine at the Fraunhofer Institute for Toxicology and Experimental Medicine. This proof of pharmacology study is designed to assess the effect of repeat oral doses of EP395 on inflammation in the lung induced by inhaled LPS.
The results of the study will give key data on the anti-inflammatory effects of EP395. For more information on the study, see ClinicalTrials.gov (NCT05516316).
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-causing inflammation.
Commenting on the study, EpiEndo’s Chief Medical Officer, Ginny Norris, said: “Commencing this study is the next major milestone in the development of EP395. We look forward to the valuable data that it will generate which will be key as we plan the next phase of clinical development.”
Principal Investigator, Prof Jens Hohlfeld, added: “This pharmacology study will provide crucial clinical insights that highlight the potential for this exciting new class of therapeutic.”
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 bacterial resistance, called Barriolides, with promise as first-in-class disease-modifying 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 which avoids bacterial resistance, is barrier strengthening and anti-inflammatory for the treatment of COPD.
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Keywords: Humans; Chronic Disease; Pulmonary Disease, Chronic Obstructive; Macrolides; Lung; Inflammation; Anti-Inflammatory Agents; Epithelium; Epithelial Cells; Lipopolysaccharides; Biological Products; Drug Development; Clinical Trials, Phase I as Topic; Pharmaceutical Preparations; Iceland
Published by B3C newswire