Successful completion of Phase I Study for lead asset EP395

EpiEndo Pharmaceuticals, the clinical-stage biopharmaceutical company developing disease-modifying therapeutics for chronic respiratory disorders, has completed its Phase I First Time in Human (FTIH) study with EP395 in healthy subjects. 

It is the first non-antibiotic macrolide to go into clinical development – targeting COPD. The study’s Principal Investigator was MEUs Medical Director Professor Dave Singh, professor of clinical pharmacology and respiratory medicine at the University of Manchester. It was designed to assess the safety and tolerability of ascending single and multiple (up to 28 days) doses of the Barriolide™ EP395, administered as oral capsules in healthy subjects. EP395 was well tolerated and with pharmacokinetics consistent with once daily dosing. 

Principal Investigator, Prof Dave Singh, 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.”

EpiEndo will begin Phase Ib and Phase IIa studies with EP395 later this year, with top-level data to become available during 2023. The Phase Ib study will be a proof of pharmacology study in healthy volunteers. The Phase IIa study will assess the safety and tolerability of EP395 in patients with COPD, as well as assessing biomarkers for anti-inflammatory efficacy.

For more info on the study visit: Single and Multiple Ascending Dose Study With EP395 – Full Text View – ClinicalTrials.gov