Phase 2A Success for EpiEndo's EP395 in Treating COPD

EpiEndo Pharmaceuticals, a clinical-stage biopharmaceutical firm, has announced the successful conclusion of its Phase 2A clinical trial for EP395, a novel oral macrolide, in patients with Chronic Obstructive Pulmonary Disease (COPD). This trial marks a significant milestone in the development of a new class of anti-inflammatory therapeutics that are designed to enhance the body's natural barriers and reduce inflammation without contributing to antimicrobial resistance (AMR).

EP395 is a non-antibiotic macrolide, part of the 'Barriolides™' family, which is distinguished by its potential to mitigate inflammation and the threat of AMR. The unique approach of Barriolides™ lies in their focus on the epithelial function, which is crucial in managing chronic inflammatory disorders. Damage to the epithelial barrier is a common factor in diseases like COPD.

COPD is a leading cause of death worldwide, and with its global economic impact projected to reach $4.8 trillion by 2030, there is an urgent need for innovative treatments. The Phase 2A study of EP395 involved 61 COPD patients across six clinics in the UK and Germany. The trial aimed to evaluate the safety, tolerability, and the impact of EP395 on inflammatory biomarkers over a 12-week period.

The results indicated that EP395 is not only safe and well-tolerated but also shows positive effects on inflammatory biomarkers, similar to those observed with traditional antibiotic macrolides. Importantly, EP395 did not cause gastrointestinal side effects or hearing-related adverse events, which are common with antibiotic macrolides.

Ginny Norris, EpiEndo’s Chief Medical Officer, has expressed confidence in the data collected from the study and a recent LPS challenge study, which will guide the future clinical development of EP395. Maria Bech, the company's CEO, emphasized the significance of these findings in advancing the treatment of COPD and the potential of EP395 as an oral treatment option. The company is also exploring partnership opportunities to facilitate the development and availability of this novel therapeutic approach.

EpiEndo Pharmaceuticals is dedicated to developing first-in-class therapeutics for chronic respiratory diseases and other inflammatory conditions. Their lead product, EP395, represents a new frontier in oral, barrier-enhancing, and anti-inflammatory drugs, offering a promising treatment option for COPD patients. The World Health Organization (WHO) identifies COPD as the third leading cause of death globally, highlighting the importance of developing effective treatments to combat this disease.