First patient treated in trial of investigational splenic nerve stimulation for RA
Click Here to Manage Email Alerts
Galvani Bioelectronics has treated its first patient with a novel bioelectronic implant stimulating the splenic nerve as an experimental therapy for rheumatoid arthritis, according to a company press release.
The company, a partnership between GlaxoSmithKline and Verily Life Sciences, a subsidiary of Google parent company Alphabet Inc., announced that the successful laparoscopic implantation and therapy initiation occurred “over the last month,” as part of a small clinical study at the NHS Greater Glasgow and Clyde Health Board, in Scotland. The study marks the first time Galvani has examined its nerve stimulation treatment in the clinic for a chronic disease.
“There is a significant unmet medical need in RA patients whose disease activity is inadequately controlled with existing therapies,” René van der Merwe, MBChB, MSc, chief medical officer of Galvani Bioelectronics, said in the release. “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.”
According to the company, the primary purpose of the feasibility study is to examine the treatment’s safety in patients with moderate-to-severe RA who had an inadequate response, or intolerance, to two or more biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs).
The open-label, single-center study, which is currently recruiting for an estimated enrollment of five patients, started in October and is expected to be completed in August, according to ClinicalTrials.gov. Participants will be implanted with the Galvani bioelectronic system and receive active stimulation for 12 weeks.
In parallel with the UK study, Galvani has also initiated a larger randomized, double-blinded feasibility trial in the United States. The study is currently recruiting for an estimated enrollment of 28 participants with active RA, and is expected to be completed in January 2029. It will be split into four periods, with the first being a randomized, controlled double-blind period in which participants are assigned randomly to either active or sham stimulation. Periods two through four will be open-label and see participants assigned treatment based on responses in the prior period.
According to Galvani, splenic nerve stimulation generates nerve signals to the spleen, which have been shown to shift splenic immune cells from a pro-inflammation to an inflammation-resolving state. The “reprogrammed” immune cells circulate to the sites of injury in diseases, where they potentially reduce or resolve inflammation and associated pain, the company said.
“Immunomodulation using splenic nerve stimulation is a whole new approach to treatment that holds the promise to reduce and potentially resolve the debilitating symptoms of autoimmune diseases, such as RA, from which many patients suffer,” Roy Fleischmann, MD, lead investigator for the U.S. study and clinical professor of medicine at the University of Texas Southwestern Medical Center, in Dallas, said in the release.
Both studies are funded by Galvani.
According to the company, the Galvani bioelectronics platform is centered around the world’s first fully laparoscopically implanted neurostimulator. It was designed to be “easily programmed” by the treating physician via a wirelessly connected tablet, the company said. Patients can also monitor and control their therapy and charge their implant wirelessly.
“The first patient receiving experimental therapy is an important milestone for this potential new treatment,” Christopher Corsico, senior vice president for development at GlaxoSmithKline and chairman of the board at Galvani, said in the release. “These initial studies will guide future development in rheumatoid arthritis, an area of considerable unmet medical need despite currently available treatments, and other potential areas of unmet need. GSK looks forward to continuing to work with Verily as both companies support Galvani’s mission and vision to bring targeted bioelectronic therapies to those in need.”
Read more about
Click Here to Manage Email Alerts