EpiEndo Pharmaceuticals has successfully concluded its Phase 2A clinical trial evaluating EP395, a novel oral therapeutic for Chronic Obstructive Pulmonary Disease (COPD).
•Safety and Tolerability: EP395 exhibited a favorable safety and tolerability profile, similar to antibiotic macrolides.
•Biomarker Effects: EP395 demonstrated beneficial effects on inflammatory biomarkers, indicating its potential to reduce disease-causing inflammation.
•No Antibiotic-Related Side Effects: Unlike antibiotic macrolides, EP395 did not cause gastrointestinal adverse events or hearing-related issues.
COPD is the third leading cause of death worldwide, and current treatment options are limited. EP395 represents a novel therapeutic approach that addresses the underlying epithelial barrier dysfunction associated with COPD.
The Phase 2A study enrolled 61 adults with COPD who received EP395 or placebo once daily for 12 weeks. Endpoints included safety, tolerability, and the impact of EP395 on inflammatory biomarkers.
EpiEndo plans to use the positive results from this trial and its recent LPS challenge study to advance the clinical development of EP395. The company is exploring partnering options to accelerate the development and delivery of this innovative therapy to patients.
EP395 is an orally available, non-antibiotic macrolide or “Barriolide™.” Barriolides™ target epithelial function, a key component of the body’s natural defense systems. By enhancing this barrier, EP395 can reduce inflammation and limit the risk of antimicrobial resistance.
EpiEndo Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics that address chronic inflammatory disorders by targeting epithelial function. Its pipeline includes EP395 and other preclinical candidates for respiratory, gastrointestinal, and dermatological conditions.
Source link: http://www.businesswire.com/news/home/20240410505161/en/EpiEndo-reports-Phase-2A-results-for-lead-asset-EP395-in-COPD
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
