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

Periodic Reporting for period 2 - BRONCHOTHELIN (The first-in-class disease-modifying drug for chronic airway disorders)

Reporting period: 2021-01-01 to 2021-12-31

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 EP395 (Bronchothelin), 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.
EpiEndo achieved its main objective for 2020 in December 2020 when we received an approval from MHRA (UK) on our CTA (Clinical Trial Application). Our Phase 1 Clinical Trial (first-in-human) began in Q1 2021 and finished at the start of January 2022. The results show that EP395 can be dosed up to 750 mg as single dose without any side effects and adverse events and with 375 mg once daily up to 28 days. The final report is expected to be available in early Q2 2022.

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

In 2020 and 2021 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.

EpiEndo raised 22.7 million in 2021, with the EIC Fund as one of the lead investors. These funds will take the company through clinical phase 1b & 2a (MS3).
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 are working on new developing new Barriolides for non-airway indications and are therefore expanding our discovery team and will have 4 biologist and 5 chemists working full-time before end of Q1 2022.

With the positive results from our phase 1 we are more than hopeful to bring the first non-antibiotic macrolide to the market.
EpiEndo Team