EpiEndo: Successful Completion of Phase I Study for Lead Asset EP395

  • First non-antibiotic macrolide to go into clinical development – targeting COPD
  • Safety, tolerability and pharmacokinetic endpoints met
  • Phase II planning underway

REYKJAVIK, Iceland–(BUSINESS WIRE)–EpiEndo Pharmaceuticals (‘EpiEndo’), 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.

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). EpiEndo is taking a novel approach to drug development for chronic respiratory diseases, focusing on enhancing the integrity of the epithelial cell layer in the lung to reduce disease-causing inflammation.

The study’s Principal Investigator was 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. For more information on the study, see ClinicalTrials.gov.

Commenting on the study results, EpiEndo’s Chief Medical Officer, Ginny Norris, said:

“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.”

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.


About EpiEndo Pharmaceuticals (www.epiendo.com)

EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to inflammatory disorders that focuses on enhancement of epithelial barrier integrity as a critical pathophysiological factor underlying the etiology of a number of major diseases. Epithelial cells are a key component of the barrier that makes up human lung tissue and other organs such as the gut and skin. Compromised integrity of this barrier is implicated in the progression and non-resolution of several chronic inflammatory diseases.

EpiEndo is developing a proprietary portfolio of non-antibiotic macrolide drugs called Barriolides, with promise as first-in-class disease-modifying therapeutics, to address the huge global burden of chronic diseases of the lung and other organs where there is significant unmet medical need. EpiEndo’s lead drug candidate, EP395, aims to be the first on-market oral, non-antibiotic, barrier strengthening and anti-inflammatory macrolide for the treatment of COPD.


EpiEndo Pharmaceuticals:
Maria Bech, CEO

Email: maria.bech@epiendo.com
Tel: +354 454 0090

Instinctif Partners (media relations):

Rozi Morris / Katie Duffell

Email: epiendo@instinctif.com
Tel: +44 20 7457 2020