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Cubosomes with pH-triggered cubic phase transition enable cytosolic mRNA delivery for acute respiratory distress syndrome therapy.

Journal of controlled release : official journal of the Controlled Release Society2026-07-01PubMed
Total: 76.0Rigor: 7Innovation: 9Journal: 8Clinical: 6

Summary

A virus-mimetic cubosome (VE-CB) undergoes a pH-triggered lamellar-to-cubic phase transition that enhances endosomal escape and enables cytosolic delivery of IL-10 mRNA. In murine ARDS, intranasal mIL-10@VE-CB sustained pulmonary IL-10 expression and attenuated inflammation, supporting a translational platform for inhaled mRNA therapeutics.

Key Findings

  • VE-CB exhibits a pH-triggered lamellar-to-bicontinuous cubic phase transition confirmed by SAXS and cryo-TEM.
  • The phase transition enhances membrane fusion and endosomal escape, enabling cytosolic IL-10 mRNA delivery.
  • In ARDS mice, intranasal mIL-10@VE-CB sustained pulmonary IL-10 (~462 pg/mL), reduced inflammatory infiltration and cytokines, and restored macrophage efferocytosis.

Clinical Implications

If safety and efficacy translate to humans, inhaled IL-10 mRNA could provide targeted anti-inflammatory therapy in ARDS while minimizing systemic exposure, potentially complementing lung-protective ventilation.

Why It Matters

Introduces a structurally engineered delivery vehicle enabling efficient, localized mRNA therapy for ARDS—an area with no approved disease-modifying treatments.

Limitations

  • Preclinical animal data without human safety or pharmacokinetic evaluation.
  • Long-term durability, dosing optimization, biodistribution, and off-target effects not fully characterized.

Future Directions

Scale-up manufacturing, GLP toxicology and large-animal inhalation studies, first-in-human trials, and comparative studies versus lipid nanoparticles or viral vectors; explore additional anti-inflammatory or reparative mRNA cargos.

Study Information

Study Type
Cohort
Research Domain
Treatment
Evidence Level
V - Preclinical in vivo and in vitro experimental evidence supporting a therapeutic concept.
Study Design
OTHER