EpiEndo reports Phase 2A results for lead asset, EP395, in COPD

EpiEndo Pharmaceuticals (?EpiEndo' or the ?Company'), a clinical-stage biopharmaceutical company developing a new class of oral, barrier-enhancing, anti-inflammatory therapeutics addressing chronic airway diseases, announces the successful completion of its Phase 2A clinical trial for EP395 in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).

EP395 is the most advanced of EpiEndo's orally available, non-antibiotic macrolides or ?Barriolidestm', which reduce inflammation while also limiting the antimicrobial resistance (AMR) threat. Barriolidestm offer a unique treatment approach to inflammatory disorders, which focuses on the role of epithelial function in chronic inflammatory disorders. Damage of this barrier is implicated in several chronic inflammatory diseases, including COPD.

Despite COPD being the third leading cause of death globally, there are currently limited treatment options available. With the global cost of COPD estimated to rise to $4.8 trillion by 2030*, there is a vital unmet need for new and improved therapeutics.

EpiEndo's Phase 2A study investigated the safety and tolerability of EP395 administered once-daily as oral capsules to COPD patients for 12 weeks. In addition, it assessed the effect of EP395 on a number of biomarkers. 61 adults diagnosed with COPD were enrolled in the study across six clinics in the UK and Germany. The Principal Investigators were Professor Dave Singh, Professor of Respiratory Pharmacology at the University of Manchester and Medical Director of the Medicines Evaluation Unit in the UK, and Professor Henrik Watz, of the Pulmonary Research Institute at the Lungen Clinic, Grosshansdorf, Germany. For more information on the study, see ClinicalTrials.gov (NCT05572333).

The 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.

EpiEndo's Chief Medical Officer, Ginny Norris, commented:

"The results from this study together with those from our recently completed LPS challenge study provide a good dataset on which to progress the clinical development of EP395."

Maria Bech, EpiEndo's Chief Executive Officer, added:

"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."

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

About EpiEndo Pharmaceuticals (www.epiendo.com)

EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to inflammatory disorders that focuses on the role of epithelial function in various inflammatory disorders.

Epithelial cells are a key part of the barrier that makes up human lung tissue and other organs such as the gut and skin. Damage to this barrier is implicated in several chronic inflammatory diseases.

EpiEndo's new class of orally available macrolides, with reduced antimicrobial resistance (AMR) potential, known as ?Barriolidestm', show promise as first-in-class therapeutics for chronic respiratory diseases as well as other inflammatory indications. EpiEndo's lead asset, EP395, was the first Barriolidetm to enter clinical trials, for chronic obstructive pulmonary disease (COPD).

EP395 aims to be the first on-market oral, barrier-enhancing and anti-inflammatory drug, which has the potential to be a unique and impactful treatment option for COPD patients. According to the WHO, COPD is the third leading cause of death globally, and the global economic burden of COPD is projected to cost $4.8 trillion by 2030.