A treatment approach developed at Johannes Gutenberg University Mainz is moving toward its first clinical trial. Researchers are developing a skin patch that delivers low-dose theophylline and is intended to stimulate the repair of damaged myelin\u2014the protective sheath surrounding nerve fibers affected in multiple sclerosis.<\/p>\n
The project has received EUR 1.1 million in support from ForTra gGmbH for Research Transfer, a subsidiary of the Else Kr\u00f6ner-Fresenius Foundation. This funding will support pharmaceutical development of the patch and preparation for testing according to Good Manufacturing Practice standards.<\/p>\n
Why remyelination matters<\/strong><\/p>\n Multiple sclerosis is a chronic inflammatory disease in which immune activity damages myelin in the brain and spinal cord. Current disease-modifying therapies mainly reduce inflammation and lower the risk of relapses or new lesions.<\/p>\n However, no approved treatment specifically rebuilds myelin that has already been damaged. This repair process is called remyelination. Promoting remyelination could, in principle, help protect nerve fibers and support recovery, but it remains an important unmet therapeutic goal.<\/p>\n The scientific idea<\/strong><\/p>\n The Mainz research team, led by Professor Claire Jacob, has studied myelin regeneration for more than 20 years. The researchers identified histone deacetylase 2, or HDAC2, as an enzyme involved in the cellular processes required for myelin repair.<\/p>\n They then investigated whether theophylline\u2014a long-established medicine previously used at higher doses for asthma and other respiratory conditions\u2014could increase HDAC2 activity. In mouse studies, low-dose theophylline was associated with increased HDAC2 activity and improved rebuilding of myelin.<\/p>\n These findings are preclinical. Results in mice cannot establish that the treatment will promote remyelination or improve neurological function in people with MS.<\/p>\n Why use a patch?<\/strong><\/p>\n The researchers aim to deliver a small amount of theophylline continuously over several days. To achieve this, they developed a transdermal patch that releases the drug through the skin.<\/p>\n A patch may help maintain a relatively stable, low exposure compared with intermittent dosing. It also provides a practical way to investigate whether the dose needed for the proposed remyelination effect can be delivered safely.<\/p>\n The patch will first be transferred to a German manufacturer for optimization and production under GMP conditions. GMP compliance is required before a medicinal product can be tested in human clinical trials.<\/p>\n What the first trial will examine<\/strong><\/p>\n The planned phase I trial at Mainz University Medical Center will involve healthy volunteers. Its main objectives will be:<\/p>\n Whether the patch adheres reliably.<\/p>\n Whether it is tolerated by participants.<\/p>\n How much theophylline passes through the skin.<\/p>\n Whether the delivery system produces the intended exposure.<\/p>\n This phase will not determine whether the patch repairs damaged myelin or benefits people with MS. Testing healthy volunteers is an initial safety and drug-delivery step, not an efficacy trial in patients.<\/p>\n Only later controlled studies in people with MS can determine whether the approach promotes remyelination, improves function, and has an acceptable safety profile.<\/p>\n The significance of the project lies in its therapeutic goal: complementing inflammation control with a treatment designed to repair existing myelin injury. Whether that goal can be achieved in patients remains an important question for the next stages of research.<\/p>\n