EP395 receives INN name recognizing first-in-class drug status

REYKJAVIK, ICELAND – 17 December 2024 – EpiEndo Pharmaceuticals (‘EpiEndo’ or the ‘Company’), a clinical-stage biopharmaceutical company with a unique approach to respiratory diseases, focusing on EP395, has received an INN (International Non-proprietary Name or generic name) from the World Health Organisation for its lead clinal drug candidate.

EP395 has received the INN name glasmacinal. EP395/glasmacinal is an oral drug which enhances the host defence response to inhaled pathogens and is anti-inflammatory. The name glasmacinal is inspired by its origins in Iceland, referring to glaciers (glas-) and using the WHO designated suffix -macinal, which means a non-antibacterial macrolide agent with anti-inflammatory activity. This is a new drug class, making glasmacinal a first-in-class drug.

Due to this new name and the findings from its recent clinical studies, presented at the ERS Congress in September 2024, EpiEndo has updated its website content to reflect the name glasmacinal and the increased understanding of how it works.

Glasmacinal comes from EpiEndo’s portfolio of Barriolides™, which are designed and developed based on their epithelial effects in-vitro and lack of antibiotic activity. Data from the clinical studies show that glasmacinal enhances the host defence response to inhaled pathogens and is anti-inflammatory. The acute host defense response is part of the innate immune response to pathogens (such as virus, bacteria and pollution). The effects demonstrated with glasmacinal in the clinical studies so far support the expectation that it will have beneficial effects in reducing exacerbations of COPD as is seen with anti-microbial macrolides, such as azithromycin.

In addition, EpiEndo has added some new features to the website, including a full list of its publications and details of all clinical trials conducted, ongoing or in planning.

EpiEndo’s CEO, Maria Bech, commented:

“We are proud that EP395’s unique profile has been recognized by the WHO as a first-in-class drug and has established a new drug class. I am delighted to share the name ‘glasmacinal’.

“Following the recent completion of some clinical trials, we are building a better understanding of how glasmacinal works in humans and therefore its potential as an effective treatment for COPD.

“We hope that sharing these insights on our updated website will help further understanding of the potential of our Barriolides™ and glasmacinal in particular, and that the interested reader will easily find more information about our development and publications”.

-ENDS-

Contact:

EpiEndo Pharmaceuticals:
Maria Bech, CEO
+354 454 0090­­­

Vigo Consulting (media relations):
Rozi Morris
+44 20 7390 0230
epiendo@vigoconsulting.com

About EpiEndo Pharmaceuticals (www.epiendo.com)

EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to chronic respiratory diseases. It was founded on the knowledge that macrolide antibiotics such as azithromycin reduce exacerbations of COPD and other respiratory diseases - effects beyond their antibacterial properties.

This led EpiEndo to develop a new class of orally available macrolides, with reduced antimicrobial resistance (AMR) potential, known as ‘Barriolides™’. These show promise as first-in-class therapeutics for chronic respiratory diseases. EpiEndo’s lead asset, glasmacinal (EP395), was the first Barriolide™ to enter clinical trials for chronic obstructive pulmonary disease (COPD).

Glasmacinal aims to be the first on-market oral, anti-inflammatory drug which also enhances the host defense response to inhaled pathogens and has the potential to be a unique and impactful treatment option for COPD patients beyond current standard treatment with inhaled bronchodilators and corticosteroids. According to the WHO, COPD is the third leading cause of death globally, and the global economic burden of COPD is projected to cost $4.8 trillion by 2030.