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02 Nov 2023

Initiation of drug-drug interaction study for EP395

REYKJAVIK, ICELAND – 2 November 2023 – EpiEndo Pharmaceuticals (‘EpiEndo’ or the ‘Company’), a clinical-stage biopharmaceutical company developing a new class of oral, barrier-enhancing, anti-inflammatory therapeutics addressing chronic airway diseases, has initiated a healthy volunteer drug-drug interaction (DDI) clinical trial for lead compound, EP395.

This is a an open-label, healthy subject, two-part study assessing the potential key drug-drug interactions (DDIs) with EP395 and will involve 36 healthy volunteers in total. It is being conducted in Sweden, in collaboration with CTC Clinical Trial Consultants AB and led by Dr Björn Schultze, MD.

This is the IND-opening trial for EP395, and it has received regulatory and ethics approvals in Sweden. The trial has begun screening, and results are expected in Q1 2024.

Ginny Norris, Chief Medical Officer at EpiEndo Pharmaceuticals, commented,

“By assessing the potential for clinical drug-drug interactions with EP395 we aim to ensure as broad a range of patients as possible can be enrolled into our next planned study looking at exacerbation reduction. The data from this study is crucial in preparing for larger clinical trials."

Contact

EpiEndo Pharmaceuticals:

Maria Bech, CEO

E-mail: maria.bech@epiendo.com

Tel: +354 454 0090­­­

Instinctif Partners (media relations):

Rozi Morris

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.