EpiEndo gets regulatory approval for first patient study of first non-antibiotic macrolide

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lungs lung disease

EpiEndo Pharmaceuticals, a clinical-stage biopharma company developing therapeutics for chronic inflammatory diseases, has received regulatory approval to begin a phase 2a clinical trial.

The trial will be with lead molecule EP395 in COPD (chronic obstructive pulmonary disease) patients, an orally available macrolide or ‘Barriolide,’ with reduced antimicrobial resistance potential. It 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 six clinics in the U.K. and Germany. The principal investigator of the study is Dave Singh, professor of respiratory pharmacology at the University of Manchester, and medical director of the medicines evaluation unit.

12-week study

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.

In this study, EP395 will be administered to COPD patients for the first time. Patients will receive either EP395 or placebo as oral capsules once-daily for 12 weeks. Safety and tolerability will be assessed, as well as effect on lung function, lung inflammation and systemic inflammation. Patients’ symptoms and quality of life will be assessed with questionnaires. In a sub-set of patients, bronchoscopies will be conducted, to investigate exploratory biomarkers in bronchial brushings and bronchoalveolar lavage.

The results of the study are expected in the second half of next year (2023) and will provide key data on EP395 in a COPD population.

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.”

EpiEndo – novel approach

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. This data came from the global economic burden of noncommunicable diseases world economic forum in Geneva.

Singh, said: “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.”

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