Regulatory approval given to Iceland’s EpiEndo for study of COPD treatment

August 31, 2022 - 2 minutes
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A treatment for chronic respiratory disorders will be the subject of a clinical trial in Iceland after regulatory and ethics approval was granted.

EpiEndo Pharmaceuticals will start a clinical trial of its lipopolysaccharide challenge with lead molecule EP395.

Available orally, EP395 is an macrolide or Barriolide with reduced antimicrobial activity which aims to address the unmet need for the treatment for chronic obstructive pulmonary disease (COPD).

Hannover

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.

Hohlfeld, said: “This pharmacology study will provide crucial clinical insights that highlight the potential for this exciting new class of therapeutic.”

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.

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Key data

The results of the study should give key data on the anti-inflammatory effects of EP395. 

EpiEndo Pharmaceuticals looks at 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.

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.”

Epithelial barrier

EpiEndo Pharmaceuticals is a clinical-stage biopharmaceutical company approaching inflammatory disorders that focus on enhancement of epithelial barrier integrity as a critical pathophysiological factor underlying the etiology of a number of major diseases.

The company is developing a portfolio of macrolide drugs, while avoiding bacterial resistance, called Barriolides. 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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