The company initiated the use of splenic nerve simulation last month as part of a small clinical trial at the NHS Greater Glasgow & Clyde Health Board in Scotland.
Galvani Bioelectronics shared that it has started on the first patient in its feasibility study of a proposed therapy for rheumatoid arthritis.
The company initiated the use of splenic nerve simulation last month as part of a small clinical trial at the NHS Greater Glasgow & Clyde Health Board in Scotland. This is Galvani’s first attempt to evaluate this investigational treatment in a clinical setting.
The study is all about using Galvani’s novel bioelectronics platform, which has the ability to stimulate the splenic nerves that are specific to and near individual visceral organs in chronic diseases. This method sends nerve signals to the spleen, which researchers observed can shift splenic immune cells from an inflammatory state to one that’s inflammation-resolving. By reprogramming the immune cells to reach the site of injury in diseases, there is a strong potential to reduce or even treat the inflammation and pain.
“There is a significant unmet medical need in RA patients whose disease activity is inadequately controlled with existing therapies. We’re proud of entering our first investigational treatment into the clinic which we hope will offer a new treatment option to patients suffering from RA, bringing durable relief without many of the side effects often seen with existing RA therapies,” said Dr. René van der Merwe, the chief medical officer of Galvani, in a statement.
Galvani’s platform has been tailored to work on the nerves to visceral organs and can be easily controlled by the physician using a wireless tablet. Patients can also keep track of and manage their therapy wirelessly. It is laparoscopically implanted.
The primary purpose of the U.K.-based feasibility study is to evaluate if the platform is safe to use in patients diagnosed with moderate-to-severe rheumatoid arthritis and respond insufficiently or do not respond at all to at least two biologic or targeted anti-rheumatic medications. Galvani also started a more extensive feasibility study to assess the platform’s safety and effectiveness. Enrollment is ongoing for patients in Austin, Anniston, New York, Dallas and nearby locations.
“The innovative design, rapid development, and rigorous testing of the bioelectronics platform are a combined major achievement by the Verily and Galvani team. We look forward to bringing the wide-ranging potential of splenic nerve stimulation to the clinic as a hopeful new treatment option for people suffering with rheumatoid arthritis,” noted Stephen Gillett, the president and chief operating officer of Verily and member of the Galvani board of directors.
Galvani was formed through a strategic partnership between Verily Life Sciences and GlaxoSmithKline in 2016, with the goal to develop targeted neuromodulation therapies. As of this writing, the Galvani platform is being used for investigational purposes only and does not have approval for use beyond clinical research settings.
