Researchers in Germany have secured €1.1m to advance an MS skin patch designed to deliver an asthma drug and promote repair of damaged myelin.
The experimental patch delivers low doses of theophylline, a drug used to treat respiratory conditions including asthma, through the skin over several days.
Preclinical studies found that theophylline helped promote myelin repair. Myelin is the protective coating around nerve fibres that helps electrical signals travel efficiently.
The research team at Johannes Gutenberg University Mainzhas spent more than 20 years investigating how the nervous system repairs damaged myelin.
Multiple sclerosis occurs when the immune system mistakenly attacks myelin in the brain and spinal cord. This damage, known as demyelination, disrupts nerve signalling and can cause fatigue, pain, movement problems and cognitive changes.
Claire Jacob, professor at Johannes Gutenberg University Mainz and leader of the team, said: “With this funding, we are taking a decisive step toward our goal of translating our research findings into a potential treatment for people with MS.
“Our long-term goal is to develop a therapy that not only slows the progression of the disease, but also helps the nervous system repair damage that has already occurred.”
Existing disease-modifying treatments primarily reduce inflammation and prevent relapses, but there is no approved treatment specifically designed to promote remyelination, the process of repairing damaged myelin.
Researchers found that increasing the activity of histone deacetylase 2, or HDAC2, an enzyme involved in regulating gene activity, could promote processes associated with remyelination.
They later identified theophylline as a potential activator of HDAC2. In mouse studies, low-dose theophylline increased HDAC2 activity and promoted myelin rebuilding in the nervous system.
To deliver the low dose needed for remyelination, the researchers worked with a team led by Peter Langguth, professor at Johannes Gutenberg University Mainz. Together, they developed a transdermal patch that continuously delivers a small amount of theophylline through the skin over several days.
Previous preclinical testing received €140,000 from the Mainz Science Foundation.
The new €1.1m grant was awarded by ForTra gGmbH for Research Transfer, a subsidiary of the non-profit Else Kröner-Fresenius Foundation.
It will support further development and the transfer of the patch to a German manufacturer for large-scale production that meets Good Manufacturing Practice standards, the quality requirements medicines must meet before human testing.
The researchers plan to test the patch in a Phase 1 clinical trial involving healthy volunteers.
The study will primarily assess whether the patch adheres properly to the skin, is well tolerated and delivers theophylline through the skin as intended.
If that stage is successful, the team plans a multicentre Phase 2 trial involving people with MS in Germany and is seeking additional funding.
That trial could provide the first opportunity to determine whether the treatment promotes remyelination in people with MS.
