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The first-in-class disease-modifying drug for chronic airway disorders

Project description

A novel disease-modifying drug for chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) is a progressive lung and airway disease affecting more than 250 million people annually. Currently, it is incurable. Available therapies include bronchodilators and anti-inflammatory corticosteroids, which provide only symptomatic relief. EpiEndo Pharmaceuticals has selected EP395 as it candidate drug for phase 1 clinical trials that will start in Q3 2020. EP395 has the potential to be a first-in-class disease-modifying treatment for COPD. It is a non-antibacterial macrolide with an excellent safety and efficacy profile and has the potential to achieve up to 50 % reduction in COPD hospitalisations and mortality. The current EU-funded BRONCHOTHELIN project aims to move the project from pre-clinical stage through phase 1a, first-in-human, clinical trials.

Objective

EpiEndo Pharmaceuticals is a drug development company focused on developing novel drugs that target epithelial differentiation and enhance regeneration and barrier function. In contrast to the prevailing anti-inflammatory approach to respiratory drug discovery, EpiEndo has come up with a novel paradigm-changing platform to develop drug candidates that alter (respiratory) epithelial stem cell differentiation and enhance epithelial regeneration of the airway epithelium.

By rational design we have discovered and developed Bronchothelin, is the first-in-class disease-modifying treatment for Chronic Obstructive Pulmonary Disease (COPD), a non-antibacterial macrolide with excellent safety and efficacy profile, poised to provide 50% reduction of COPD hospitalisations and preventing COPD-related mortality, without inducing antimicrobial resistance associated with the use of macrolide antibiotics. COPD is a progressive and currently incurable lung and airway disease affecting >250M patients annually, causing >3.17M deaths globally. Current therapies include inhaled bronchodilators or anti-inflammatory corticosteroids that provide symptomatic relief but fail to slow down the progression of the disease or reduce associated mortality.

22M COPD patients are being treated globally and the COPD drug market is predicted to grow from >€13B to >€18B in 2026. Even when capturing a conservative 3.5% market share, Bronchothelin has a blockbuster potential with >€4.9B sales in EU and US combined, predicted 5 yrs after market introduction (2027). Bronchothelin is now ready to enter FIH study. After completing the Ph2 clinical trial, we aim to commercialize through a licensing deal (2023) with a pharma company for further clinical development (Ph3) and sales, generating an estimated €150-€230 million in upfront/milestone payments and additional 8% royalties on sales, being €412M in year 5 after launch.

Fields of science (EuroSciVoc)

CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.

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Coordinator

EpiEndo Pharmaceuticals ehf
Net EU contribution
€ 2 500 000,00
Address
Eidistorg 13-15, 3rd floor, Innovation House
170 Seltjarnarnes
Iceland

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Ísland Ísland Höfuðborgarsvæði
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
€ 3 578 020,00