
Clinical and Pre-Clinical Data on the Novel Barriolide, EP395 (glasmacinal), Published in Three Articles in
REYKJAVIK, Iceland--(BUSINESS WIRE)--EpiEndo Pharmaceuticals ('EpiEndo' or the 'Company'), a clinical-stage biopharmaceutical company developing a new class of oral anti-inflammatory drugs which enhance the host defence response to inhaled pathogens, has had three articles published in peer-reviewed journal, Pulmonary Pharmacology and Therapeutics.
These publications describe the potential for EpiEndo's lead asset EP395, also known as 'glasmacinal', to be of therapeutic benefit in the treatment of COPD and support its continued clinical development. The article 'Effect of EP395, a novel anti-inflammatory macrolide, in an inhaled lipopolysaccharide challenge model in healthy volunteers: a randomised controlled trial' reports that EP395 enhances the host defence response to inhaled LPS whilst reducing pro-inflammatory mediators. The paper was co-authored with investigators from Fraunhofer Institute for Toxicology and Experimental Medicine who conducted the study.
The second article, 'Effects of EP395, a novel macrolide, on acute neutrophilic airway inflammation' describes preclinical data that demonstrate EP395 has comparable inhibitory effects on acute neutrophilic airway inflammation to azithromycin, which is used chronically off-label for its immunomodulatory properties to reduce COPD exacerbations.
Finally, 'A novel macrolide, EP395, with reduced antibacterial activity and an enhancing effect on respiratory epithelial barrier ' reports that EP395 has negligible antibiotic activity and enhances the barrier function of the respiratory epithelium.
Maria Bech, CEO of EpiEndo Pharmaceticals commented:
'It is great to see the publication of this clinical and pre-clinical research in a peer-reviewed journal, highlighting the efficacy we are seeing with glasmacinal in neutrophilic inflammation.
'The anti-inflammatory effects of glasmacinal are comparable to those seen with azithromycin preclinically, but without anti-microbial activity. The clinical LPS study shows that EP395 enhances the host defence response to inhaled challenge, supporting our hypothesis that glasmacinal could be effective in reducing exacerbations in COPD but without developing anti-microbial resistance.
'We continue to develop glasmacinal as a potential new oral treatment option for COPD patients, aiming to bring additional therapeutic options to patients with chronic respiratory diseases.'
Professor Clive Page, Emeritus Professor of Pharmacology, King's College London and Chairman of EpiEndo Pharmaceutical's Scientific Advisory Board added:
'These exciting new data demonstrate glasmacinal's effect on neutrophilic inflammation both in a clinical study and in established non-clinical models of airways disease. These novel findings, coupled with data presented at ERS in 2024 on EP395's anti-inflammatory effect on eosinophilic inflammation (caused by allergens), demonstrate the broad anti-inflammatory activity of this drug that has the potential to provide a novel, groundbreaking approach to treat patients with COPD, irrespective of their type of inflammation.'
About EpiEndo Pharmaceuticals (www.epiendo.com)
EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to chronic respiratory diseases that focuses on the role of epithelial function in various inflammatory disorders.
EpiEndo's new class of orally available macrolides, with reduced antimicrobial resistance (AMR) potential, known as 'Barriolides™', show promise as first-in-class therapeutics for chronic respiratory diseases as well as other inflammatory indications. EpiEndo's lead asset, glasmacinal, was the first Barriolide™ to enter clinical trials, for chronic obstructive pulmonary disease (COPD).
Glasmacinal aims to be a first on-market oral treatment which is anti-inflammatory and enhances the host defense response to inhaled pathogens such as viruses, bacteria & pollution. Therefore, glasmacinal has the potential to become an impactful treatment in reducing exacerbations in patients with COPD.
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.

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About the Phase 2 WILLOW Clinical Study WILLOW (NCT05162586) is a randomized, double-blind, placebo-controlled Phase 2 proof of concept and dose-finding study designed to evaluate the efficacy and safety of enpatoran in patients with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). The study incorporates a basket design, including two cohorts – Cohort A including patients with CLE or SLE with active lupus rash and Cohort B including patients with active SLE. The WILLOW study aims to advance the understanding of enpatoran's therapeutic potential and to help address significant unmet needs in lupus treatment. About Lupus Erythematosus Lupus erythematosus is a chronic autoimmune disease that can affect various parts of the body, including the skin, joints, kidneys and other organs. It occurs when the immune system mistakenly attacks healthy tissues, leading to inflammation, pain and potential organ damage. There are multiple types of lupus, with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) being two primary forms. Symptoms can range from mild to life-threatening, often including fatigue, joint pain, rashes and organ involvement. Lupus disproportionately impacts women and people of color, and despite available treatments, many patients experience unmet needs due to limited efficacy or side effects. EMD Serono in Neurology and Immunology EMD Serono has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company's current MS portfolio includes two products for the treatment of relapsing MS – Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine) tablets. EMD Serono aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to EMD Serono's commitment to MS, the company also has a pipeline focusing on discovering new therapies that have potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE) and generalized myasthenia gravis (gMG). About EMD Serono, Inc. EMD Serono - the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada - aspires to create, improve and prolong life for people living with difficult-to-treat conditions like infertility, multiple sclerosis and cancer. The business is imagining the future of healthcare by working to translate the discovery of molecules into potentially meaningful outcomes for people with serious unmet medical needs. EMD Serono's global roots go back more than 350 years with Merck KGaA, Darmstadt, Germany. Today, the business has approximately 1,050 employees around the country with commercial, clinical and research operations in Massachusetts. About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2024, Merck KGaA, Darmstadt, Germany, generated sales of € 21.2 billion in 65 countries. The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. 1 Cojocaru M, Cojocaru IM, Silosi I, Vrabie CD. Manifestations of systemic lupus erythematosus. Maedica (Bucur). 2011 Oct;6(4):330-6. PMID: 22879850; PMCID: PMC3391953. View source version on Contacts Media Relations Phone: +1 781 427 1892 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data