Completion of proof of pharmacology study for lead asset EP395

The study was conducted in 49 healthy adults under the supervision of Professor Jens Hohlfeld, Director of Airway Research and Aerosol Medicine at the Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover Medical School, Germany.

This proof of pharmacology study was a double-blinded, randomized, placebo-controlled study designed to assess the effect of repeat oral doses of EP395 on inflammation and epithelium function induced by inhaled lipopolysaccharide (LPS), an established model for investigating novel drugs for the treatment of COPD. For full study information, see ClinicalTrials.gov (NCT05516316).

Although the primary endpoint (a statistically significant effect on IL-8) was not met, there were positive effects seen on a number of markers of inflammation and epithelial function with EP395 treatment. This clinical data therefore supports our preclinical data that demonstrates that EP395 has both anti-inflammatory and epithelial enhancing effects.

EpiEndo’s phase 2a study in COPD patients (NCT05572333) has completed recruitment, and results are expected early in 2024 to support the further development of EP395 as a novel treatment for patients with COPD.

EP395 is the first of EpiEndo’s new class of orally available macrolide, with reduced potential to cause antimicrobial resistance, known as a ‘Barriolide’™. It shows promise as a first-in-class therapeutic for chronic respiratory diseases as well as other inflammatory indications.

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

“The results from this study support our hypothesis that EP395 can affect both inflammation and epithelial function, which is key for treating COPD and other inflammatory diseases of the lung.

The study has provided us with a rich data set and we would like to thank Prof Hohlfeld and his team. The results from our phase 2a study in patients are now eagerly awaited as we continue our work to bring much needed new treatments to COPD patients.”

Contact

EpiEndo Pharmaceuticals:

Maria Bech, CEO

E-mail: maria.bech@epiendo.com

Tel: +354 454 0090­­­

Instinctif Partners (media relations):

Rozi Morris / Batoul Ali

Tel: +44 20 7457 2020

About EpiEndo Pharmaceuticals (www.epiendo.com)

EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to inflammatory disorders that focuses on the enhancement of epithelial barrier integrity to reduce disease-causing inflammation.

Epithelial cells are a key part of the barrier that makes up human lung tissue and other organs such as the gut and skin. A breakdown of this barrier is implicated in several chronic inflammatory diseases.

EpiEndo’s new class of orally available macrolide, with reduced antimicrobial resistance (AMR) effect, known as a ‘Barriolide™’, shows promise as a first-in-class therapeutic for chronic respiratory diseases as well as other inflammatory indications. EpiEndo’s lead asset, EP395, is the first Barriolide™ to enter into Phase 2 clinical trials, for chronic obstructive pulmonary disease (COPD).

EP395, aims to be the first on-market oral, barrier-enhancing and anti-inflammatory drug, which has the potential to be a unique and impactful treatment option for COPD patients. According to the WHO, COPD is the third leading cause of death globally, and the global economic burden of COPD projected to cost $4.8 trillion by 2030.