EpiEndo Pharmaceuticals has obtained regulatory and ethics approval to begin a Lipopolysaccharide (LPS) challenge clinical trial of its lead molecule, EP395, to treat chronic obstructive pulmonary disease (COPD).
The trial will be carried out in up to 48 healthy adult subjects at the Hannover Medical School in Germany.
In this proof of pharmacology trial, the impact of repeated oral dosages of EP395 on inflammation in the lung caused by inhaled LPS will be evaluated.
The trial data will offer crucial information on the molecule’s anti-inflammatory effects.
An orally available, non-antibiotic macrolide or ‘Barriolide’, EP395 is claimed to have less antimicrobial activity to potentially treat COPD.
EpiEndo Pharmaceuticals chief medical officer Ginny Norris said: “Commencing this study is the next major milestone in the development of EP395.
“We look forward to the valuable data that it will generate, which will be key as we plan the next phase of clinical development.
Airway Research director and professor Jens Hohlfeld is acting as the principal investigator for this trial.
Hohlfeld said: “This pharmacology study will provide crucial clinical insights that highlight the potential for this exciting new class of therapeutic.”
In May this year, the company concluded the Phase I clinical trial of EP395 in healthy participants.
It analysed the safety and tolerability of ascending single and multiple oral capsules of EP395 for up to 28 days in healthy subjects.
According to the findings, EP395 was found to be well tolerated, with pharmacokinetics in line with once-a-day dosing.
EpiEndo is adopting a new approach to drug development for chronic respiratory diseases and will leverage its Barriolide compounds to boost the epithelial cell layer’s integrity in the lung to reduce disease-causing inflammation.