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Commencement of LPS challenge trial for lead candidate EP395

Regulatory approval for proof of pharmacology study for the first non-antibiotic macrolide


31 August 2022 – 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 (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.”

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