An EU-backed initiative has assembled a team to develop a nose-to-brain biologics delivery device for neonates, enlisting medtech company Eveon and other groups to support Chiesi Farmaceutici.
The European Joint Programme on Rare Diseases put out a call for companies to tackle four challenges in 2020. One of the challenges, sponsored by the Italian drugmaker Chiesi, addressed the development of a delivery system for intranasal administration of biological drugs to neonates.
Because existing ways of getting drugs across the blood-brain barrier, such as intrathecal injections, are invasive and can lead to infections, there is a need for better ways of delivering biologics to the central nervous system. Intranasal delivery devices for liquid or lipid-based particulate formulations are already available but there is a lack of technologies capable of getting biological drug formulations through nasal cavities and into the brain. Stem cells are among the modalities targeted by the initiative.
“Stem cells hold tremendous promise for regenerative medicine. Preclinical research suggest that stem cells may represent the next breakthrough in the repair of currently devastating brain injury in neonates, including stroke and hypoxic-ischemic lesions. Recent safety studies in human neonates have suggested that the nasal route may be the most efficient way to deliver stem cells in the neonatal brain,” Cliniques universitaires Saint Luc’s Maria-Roberta Cilio said in a statement.
Eveon has secured the chance to address that gap in the delivery toolkit. Working with Chiesi, Belgium’s Les Cliniques universitaires Saint Luc and the Infectious Disease Models and Innovative Therapies at the CEA in France, Eveon will try to design, develop and preclinically validate a functional prototype over the course of the 18-month project.
The brief for the project, which has a total budget of €487,500 ($496,300), calls for the collaborators to demonstrate the “efficient delivery of different biological drug formulations in the brain in vivo in large animals.” That stage of the project will include at least two animals and tissue analysis. Ideally, the team that proposed the challenge would like Eveon and its collaborators to secure a CE mark at the end.