Orally available EP395 has met all endpoints in safety and is now undergoing phase 2 planning

EpiEndo has announced the successful completion of its phase 1 first time in human study with EP395 in healthy subjects.

EP395 is the first of EpiEndo’s orally available, non-antibiotic macrolides or ‘Barriolides’ to enter clinical development and will target chronic obstructive pulmonary disease (COPD).

EpiEndo is taking a novel approach to drug development for chronic respiratory diseases and is focusing on enhancing the integrity of the epithelial cell layer in the lung to reduce disease-causing inflammation.

This is the first non-antibiotic macrolide targeting COPD to go into clinical development. EP395 has met all endpoints in safety, tolerability and pharmacokinetics. The treatment is now undergoing phase 2 planning.

Remarking on the study results, EpiEndo’s chief medical officer, Ginny Norris, said: “The successful completion of this study brings us a step closer to addressing the global burden of COPD and other airway diseases by restoring and preserving epithelial integrity and reducing inflammation without the issue of potential anti-microbial resistance.”

“We are now planning the next stage of clinical development for EP395 and look forward to initiating two clinical studies later this year including the first study with EP395 in COPD patients,” she added.

Principal investigator, Professor Dave Singh, professor of clinical pharmacology and respiratory medicine at the University of Manchester, added: “This First Time in Human study provides key clinical insights which highlight the potential for this new class of therapeutic – an encouraging step towards a new treatment for COPD.”