A clinical-stage biopharmaceutical company plays a critical role in developing new therapies for diseases that have limited or no effective treatment options. These companies focus on translating scientific discoveries into potential medicines and advancing them through preclinical research and human clinical trials. This phase is essential because it determines whether a therapy is safe, effective, and suitable for regulatory approval before it can reach patients.

Without clinical-stage biopharmaceutical companies, many promising compounds discovered in laboratories would never progress beyond theoretical research, leaving significant medical needs unresolved. These organizations also drive healthcare innovation by exploring new mechanisms of action and addressing complex diseases such as cancer, respiratory disorders, and rare genetic conditions.

In addition, they contribute to scientific advancement, workforce development, and collaboration across the pharmaceutical ecosystem, bridging the gap between academic research and commercially available treatments. Without their work, medical progress would slow considerably, limiting treatment options, delaying potential cures, and reducing the healthcare system’s ability to respond to emerging health challenges. EpiEndo Pharmaceuticals contributes to this effort by focusing on the development of innovative oral medicines for chronic respiratory diseases such as chronic obstructive pulmonary disease (COPD).

A Promising Solution for COPD Patients

EpiEndo Pharmaceuticals is a semi-virtual biopharmaceutical company based in Iceland, with teams in Sweden, Denmark, and the UK working to develop next-generation therapies for chronic respiratory diseases. Building on the observation that azithromycin can reduce exacerbations in conditions such as COPD, the company aims to address a key limitation associated with long-term antibiotic use: the risk of antimicrobial resistance, which the World Health Organization identifies as one of the greatest threats to global health.

To tackle this challenge, EpiEndo is developing glasmacinal (formerly EP395), a non-antibiotic macrolide designed to deliver the anti-inflammatory and host-defense benefits of traditional macrolides without contributing to antimicrobial resistance. Glasmacinal is being developed as an oral therapy intended to complement or potentially improve upon existing inhaled treatments such as corticosteroids and bronchodilators, offering patients a potential long-term treatment option.

COPD is currently the third leading cause of death worldwide and is characterized by irreversible airway obstruction and recurrent exacerbations. The disease is also expected to impose an estimated economic burden of $4.8 trillion globally by 2030. Exacerbations are often triggered by viruses, bacteria, or airborne irritants that overwhelm the respiratory system’s defense mechanisms and worsen airway inflammation.

Glasmacinal is designed to strengthen the body’s host defense response while reducing inflammation, with the goal of decreasing the frequency, duration, and severity of exacerbations. By doing so, it could potentially lower hospitalization rates and improve the quality of life for people living with COPD. Through the development of Barriolides™, a novel class of oral medicines, EpiEndo is exploring a new therapeutic strategy that could reshape the long-term management of COPD and other chronic respiratory diseases while addressing both patient needs and the broader societal burden of these conditions.

EpiEndo’s Core Values

Every facet of EpiEndo's operations is guided by ethical duty and integrity. The company is committed to operating with accountability, transparency, and respect for the highest standards of professionalism. Its code of conduct establishes clear expectations for ethical behavior and responsible decision-making across all areas of the business, providing guidance for employees, partners, and suppliers.

To ensure that its activities are carried out responsibly and lawfully, EpiEndo places strong emphasis on compliance with applicable laws, regulations, and industry standards. Equally important is the company’s commitment to fairness, respect, and the protection of the rights and dignity of every individual it engages with, including employees, collaborators, patients, and communities.

By adhering to these principles, EpiEndo fosters a culture built on trust, collaboration, and accountability. The company believes that maintaining high ethical standards not only strengthens relationships with stakeholders but also supports its broader mission of advancing healthcare innovation in a responsible and sustainable way.

Therapeutic Focus

A Fresh Perspective on Chronic Respiratory Disease Treatment with EpiEndo’s Glasmacinal

An Oral Option

EpiEndo is developing glasmacinal (EP395), an oral medication designed to simplify the treatment of persistent respiratory diseases such as COPD. While most current COPD therapies are delivered through inhalation or injection, glasmacinal is being explored as a convenient oral alternative that may provide patients with a more accessible and easier-to-manage treatment approach.

Improvement over Azithromycin

Preclinical research has shown that glasmacinal demonstrates efficacy comparable to or greater than azithromycin in models involving smoke exposure, air pollution, endotoxins, and viral triggers. Unlike azithromycin, glasmacinal has minimal antibiotic activity and has not shown measurable effects on the lung or gut microbiome in clinical studies, helping address concerns related to antimicrobial resistance.

Preclinical Evidence

Research conducted by EpiEndo indicates that glasmacinal can reduce both neutrophilic and eosinophilic inflammation across several disease models. The compound belongs to a class known as barriolides and is designed to strengthen the airway epithelial barrier while delivering anti-inflammatory effects. Preclinical findings also suggest that it can regulate airway immune responses and inhibit inflammatory cell migration.

Clinical Progress

Glasmacinal has been shown to be well tolerated in four clinical studies conducted to date. Early clinical findings suggest that the treatment enhances host defense responses while reducing inflammatory markers in COPD patients. Ongoing clinical programs include Phase 1 and Phase 2 studies evaluating safety, pharmacology, and drug interactions.

EpiEndo Future Vision

EpiEndo Pharmaceuticals intends to carry glasmacinal, its flagship medication candidate, through the latter phases of clinical development over the course of the next five to 10 years in order to get it closer to treating patients with chronic respiratory conditions. In order to show that the medication can lessen exacerbations in COPD patients who still have symptoms in spite of existing standard therapies, the business is getting ready for larger Phase 2b clinical research.

EpiEndo strengthens its production and regulatory capacities in tandem with clinical advancements to facilitate the next large-scale trials and potential commercialization. Additionally, the business plans to increase research on its exclusive Barriolides™ platform, investigating new therapeutic candidates and its uses in various respiratory and inflammatory diseases. EpiEndo seeks to create a new class of oral treatments that fill gaps in the management of chronic respiratory diseases through ongoing clinical research, scientific partnerships, and development funding.

Maria Bech, MSc | CEO

Maria Bech has worked in the pharmaceutical industry for thirty years. She has held important leadership roles in both clinical development and R&D, such as VP Clinical Development and Regulatory Affairs at Karo Bio AB, and has significant experience in drug development strategies, clinical programs, and study design. Maria oversaw numerous clinical initiatives and activities at AstraZeneca before taking on managerial positions.

Endocrinology, CNS, cardiovascular, respiratory, nutrition, and cancer are just a few of the therapeutic areas in which she has experience. Maria graduated from the University of Lund with an MSc in Molecular Biology.

She has board-level experience at both private and publicly traded firms in addition to her position at EpiEndo. Also, Maria has non-executive director positions at Neuronano AB and Paxman AB.

“Glasmacinal has the potential to become a unique and impactful treatment option for COPD patients with its host defense response and anti-inflammatory properties.”