Pharmosa Biopharm announced on the 30th that its inhaled new drug L608 (liposomal iloprost) presented Phase I clinical results at the European Respiratory Society (ERS 2025) Annual Congress held on the 28th in Amsterdam, Netherlands. The presentation focused on L608’s safety, tolerability, and pharmacokinetic profile, while highlighting its potential for treating chronic thromboembolic pulmonary hypertension (CTEPH). The related data have also been published on the conference’s official website.
CTEPH is a severe and rare form of pulmonary hypertension, with only three approved therapies currently available (oral or injectable), and no inhaled treatment options exist. Both patients and physicians urgently need more effective and convenient therapies to overcome existing treatment limitations. While inhaled iloprost is available on the market to dilate pulmonary vessels and improve blood flow, it is only approved for Group 1 pulmonary arterial hypertension (PAH) and not for CTEPH.
Pharmosa noted that prior clinical studies have shown potential efficacy in CTEPH, but severe patients often require higher doses. Current rapid-release inhaled formulations require six to nine daily administrations due to short drug effect duration, resulting in significant blood concentration fluctuations. In addition, the existing drug-device combination is complex to operate, limiting patient adherence and quality of life.
L608 employs liposomal sustained-release technology, which not only reduces respiratory tract irritation but also extends the drug effect up to 12 hours, overcoming the limitations of rapid-release formulations and improving treatment convenience and stability for patients. Phase I clinical trials (NCT05938946) were conducted in healthy subjects with doses ranging from 5 to 40 micrograms. Results demonstrated good safety and tolerability across all dose groups, with no serious adverse events even at the highest dose. Pharmacokinetic data confirmed that L608 prolongs iloprost’s blood half-life—normally only 20 to 30 minutes—by several folds, achieving stable and sustained plasma concentrations.
According to the latest 2025 report from Verified Market Reports, the global CTEPH market is rapidly expanding, reaching US$2.1 billion in 2024 and projected to exceed US$3.5 billion by 2033, with a compound annual growth rate (CAGR) of 6.3% from 2026 to 2033. Globally, approximately 3.8 new cases per million people occur annually, with cumulative patient numbers exceeding 100,000, indicating significant clinical demand and broad market potential.
Pharmosa Biopharm stated that L608 not only demonstrates the company’s expertise in liposomal technology but also shows clinical potential for CTEPH. Beyond its development for PAH and systemic sclerosis-related Raynaud’s phenomenon and digital ulcers (SSc-RP/DU), L608 is expected to expand into CTEPH, offering patients a novel inhaled therapy option while broadening international market opportunities.
Resource: 國邑 L608 臨床一期成果在歐洲呼吸學會發表 展現 CTEPH 治療新契機
