Positive results announced for COPD therapy


Biopharmaceutical company EpiEndo has completed a Phase IIA clinical trial for its therapy addressing chronic obstructive pulmonary disease (COPD).

EpiEndo is developing orally available, non-antibiotic macrolides, or Barriolides, that reduce inflammation while also limiting antimicrobial resistance (AMR). The company’s lead asset is EP395 and it focuses on the role of epithelial function in chronic inflammatory disorders. Damage of this barrier is implicated in several chronic inflammatory diseases, including COPD.

COPD currently has limited treatment options despite being a leading cause of death globally. By 2030, it’s estimated that the global cost of COPD will rise to $4.8 trillion by 20301, indicating a serious unmet need for new and improved therapeutics.

EpiEndo’s Phase IIA study investigated the safety and tolerability of EP395 administered once-daily as oral capsules to COPD patients for 12 weeks. It also assessed the effect of EP395 on a number of biomarkers. Sixty-one adults diagnosed with COPD were enrolled in the study across six clinics in the UK and Germany. Study results show EP395 to have tolerability and safety as well as beneficial effects on inflammatory biomarkers, as seen with antibiotic macrolides. However, in contrast to antibiotic macrolides, GI adverse events were comparable between the EP395 and placebo-treated participants, and no adverse events related to hearing were reported.

Maria Bech, EpiEndo’s Chief Executive Officer, said: “These trial results mark a crucial step forward in advancing EpiEndo’s mission to address the global burden of COPD by reducing disease-causing inflammation. The findings reported today pave the way for further development of EP395 as an oral treatment option. As we plan our next clinical steps and follow-on studies, we are also exploring our partnering options to best enable us to bring our novel therapeutic approach to patients.”

1: The Global Economic Burden of Noncommunicable Diseases. Geneva: World Economic Forum, 2011

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