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

Periodic Reporting for period 1 - BRONCHOTHELIN (The first-in-class disease-modifying drug for chronic airway disorders)

Reporting period: 2020-01-01 to 2020-12-31

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.
EpiEndo achieved its main objective for 2020 in December 2020 when we received an approval from MHRA (UK) on our CTA (Clinical Trial Applicaion). Our Phase 1 Clinical Trial (first-in-human) will begin in Q1 2021. We should have preliminary results ready by Q3/Q4 2021 but the final report will most likely not be available until Q1 2022, so there might be a delay on D2.1 / MS2.

We have our GMP-grated Bronchothelin (EP395) batch available and ready for or Phase 1. We have reached MS1.

In 2020 we have continued the development of our Barriolides and done more extensive PK and efficacy studies on EP395 and other Barriolides, but as it seems that EP395 is our best candidate for both COPD and other chronic inflammatory airway diseases we have been doing more studies on EP395 than our other Barriolides.

Our goal now is to see what airway indications, other than COPD we should focus on for EP395 as a second and third indication. We would, because of that, like to change the definition of MS4 as it is highly unlikely that we will develop a NCE (New Chemical Entity) to reach our goal but we will reach the goal and objective of WP3 and have a plan for a second indication at the end of 2021.

In this period, EpiEndo has been working with the EIB to move towards finalizing the equity part of the project. The completion of this process has taken longer than anticipated.

We have already started our fundraising for our phase 2a clinical trials and anticipate to have that finished before end of Q3 2021 (MS3).

We have begun working on a synopsis for Phase 2a study and will start working on the study protocol in Q3 2021 (D4.1). The Data Management plan has already been implemented and delivered (D4.2).
We anticipate to finish our phase 1 first-in-human clinical trials and initiate our second program towards a new indication before the end of the project.
EpiEndo Team