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 – 18 May 2022 – 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.