OUR TEAM
18 Mar 2026
British Journal of Clinical Pharmacology article reports two clinical pharmacology trials of glasmacinal (EP395)
Glasmacinal, a macrolide with negligible antimicrobial activity but with anti-inflammatory and immunomodulatory properties, was well tolerated in healthy participants and has limited potential for clinically relevant drug interactions.
REYKJAVIK, ICELAND – 19 March 2026 – EpiEndo Pharmaceuticals (‘EpiEndo’ or the ‘Company’) is developing glasmacinal, an orally available macrolide with reduced antimicrobial resistance (AMR) potential. It is the first in a new class of oral anti-inflammatory drugs that enhance the host defence response to inhaled pathogens. Glasmacinal is in clinical development as a potential treatment to reduce exacerbations of respiratory diseases, including COPD.
The article, Early clinical pharmacology evaluation of the novel anti-inflammatory macrolide, glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions was authored by the clinical trial investigators and research partners (Prof Dave Singh, Dr Johan Bylund, and Dr Björn Schultze), and EpiEndo’s Director Clinical Operations & Sciences (Dr Kate Hanrott), Clinical Pharmacology Advisor (Dr Olof Breuer), and Chief Medical Officer (Dr Ginny Norris).
The article reports the results of the glasmacinal first-in-human (FIH) trial (NCT04819854), and a drug-drug interaction (DDI) trial (NCT06118684). Both trials showed that glasmacinal was well tolerated, and when glasmacinal was administered for 28 days in the FIH trial, plasma concentrations of glasmacinal achieved the preclinical target exposure and allowed dose selection for clinical trials to assess pharmacology in man (Hohlfeld et al. 2025; Watz et al. 2025). The DDI trial was conducted to assess potentially clinically relevant interactions to facilitate progression of glasmacinal into large patient trials.
Prof Dave Singh, Principal Investigator, the Manchester Evaluations Unit commented:
“This article provides an important overview of the early clinical pharmacology work conducted with glasmacinal, which has facilitated further trials, including proof of pharmacology and patient trials. Glasmacinal is a promising treatment for COPD patients with frequent exacerbations, and I look forward to larger patient trials assessing the efficacy of glasmacinal.”
Dr Kate Hanrott, Director Clinical Operations & Sciences at EpiEndo Pharmaceuticals added:
“We’re delighted to publish the initial clinical work conducted with glasmacinal. These important trials were key for the progression of glasmacinal into proof-of-pharmacology trials, and now we’re pleased to be planning an exacerbation reduction trial in COPD patients”.
