EpiEndo Pharmaceuticals has completed its Phase I First Time in Human (FTIH) study with EP395 in healthy subjects.

EP395 is the first of EpiEndo’s orally available, non-antibiotic macrolides or ‘Barriolides’ to enter clinical development and will be targeting chronic obstructive pulmonary disease (COPD).

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The study 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.

A step closer

“The successful completion of this study brings us a step closer to addressing the global burden of COPD and other airway diseases by restoring and preserving epithelial integrity and reducing inflammation without the issue of potential anti-microbial resistance. We are now planning the next stage of clinical development for EP395 and look forward to initiating 2 clinical studies later this year including the first study with EP395 in COPD patients,” says EpiEndo’s Chief Medical Officer, Ginny Norris.

Phase Ib and IIa studies begin later this year

EpiEndo will begin Phase Ib and Phase IIa studies with EP395 later this year, with top-level data to become available during 2023, the company states. 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.

Photo of the EpiEndo team