During the last 4.5 years, an international consortium of eleven partners including EMSP, set the task of providing a more efficient, alternative option for the therapy of multiple sclerosis and other CNS diseases as a platform technology.
With success: the international consortium developed a nasal delivery system for biopharmaceuticals via the olfactory mucosa, the regio olfactoria.
Placing medications as close as possible to the site of the disease: this sounds completely believable in theory but is unfortunately not so simple in practice. While this works well for many drugs via the bloodstream or the digestive tract, it does not apply to the brain. In this case, special protective mechanisms such as the blood-brain barrier ensure that foreign substances from outside – and thus therapeutic agents and, above all, highly effective biomolecules – can reach this so important organ only with great difficulty and to a significantly reduced extent. However, especially for diseases of the central nervous system (CNS), it is crucial that the drugs reach this organ as efficiently as possible. One example is the treatment of multiple sclerosis, in which the pharmaceuticals must unfold their effect primarily in the CNS.
A gentle form of administration for treatments through the nose
For this reason, the European Union’s Horizon 2020 Research and Innovation programme-funded N2B-Patch (“Nose-to-Brain-patch”) project – that received funding under the grant agreement No. 721098 – was carried out between January 2017 and June 2021.
In contrast to treatment by nasal spray or intravenous injection directly into the bloodstream, this innovative “nose-to-brain” approach enables an active ingredient to bypass the path through the bloodstream and reach the brain directly. This is because the brain is separated from the nasal cavity only by the perforated ethmoid bone and a few additional cell layers so that the drugs can easily penetrate this barrier and reach the CNS directly over a short distance.
Future platform technology for a wide range of indications
The novel delivery system is so promising that a patent application is to be filed shortly. For the active ingredient itself can be stably formulated using the new system and can thus even be stored for days and weeks at room temperature.
Since the novel system is designed to be flexible, the method can also be used in the future as a platform technology for other CNS diseases – for example, for the therapy of strokes and Alzheimer’s disease – or even for cancer therapy.
Ended with a symposium, but research continues
In June 2021, the project officially ended with a virtual final symposium attended by experts from science and industry, but also patients and the interested public.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 721098.
Preclinical studies convincing
With the new system, the active ingredient is administered continuously and reliably to the brain over a period of up to two weeks. After that, another application must be made.
However, surveys conducted by the consortium have shown that patients do not perceive this as a burden. By enabling repeated use in a safe way for the patient, the system is suitable for long-term or even lifelong treatment. The system cannot be self-administered but must be applied by a physician or trained personnel who have appropriate skill and experience – similar to a Corona swab.
EMSP closely accompanied the project as a partner through the entire duration and thus regularly involved those affected by MS through events, campaigns or interviews.