Galvani Bioelectronics has announced that the first patient with rheumatoid arthritis (RA) has been treated through stimulation of the splenic nerve using its novel bioelectronics platform. This investigational treatment is the first in the clinic of a new class often referred to as “bioelectronic medicines” that stimulate nerves specific and near to individual visceral organs central in disease, according to a company press release.
Therapy initiation took place over the last month as part of a small clinical study at the NHS Greater Glasgow & Clyde Health Board in Scotland, marking the first time Galvani has studied its investigational treatment in the clinic for a chronic disease, the release adds.
The primary purpose of this feasibility study, approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), is to evaluate the safety of the platform in patients with moderate-to-severe RA who are incomplete responders, or are intolerant to, two or more biologic or targeted synthetic, disease-modifying antirheumatic drugs.
“Splenic nerve stimulation represents a novel and likely complementary approach for the treatment of autoimmune diseases,” said Duncan Porter, lead investigator of the study, and consultant rheumatologist at the NHS Greater Glasgow & Clyde Health Board and honorary professor at the University of Glasgow in Scotland.
Splenic nerve stimulation generates nerve signals to the spleen that in turn have been shown to shift splenic immune cells from a pro-inflammation to an inflammation-resolving state, the release continues. The reprogrammed immune cells circulate to the sites of injury in diseases, for example the joints in RA, potentially leading to the reduction or resolution of the inflammation and associated pain there.
Resulting from a major research and development effort over the last five years, the Galvani bioelectronics platform is centred around what the company claims is the world’s first fully laparoscopically implanted neurostimulator. According to the Galvani press release, it has been tailored for stimulation of nerves to visceral organs and is easily programmed by the treating physician via a wirelessly connected tablet. Patients can also monitor and control their therapy and charge their implant wirelessly.
In parallel with the UK study, Galvani has also initiated a larger US-based randomised and double-blinded feasibility study, approved by the US Food and Drug Administration (FDA) under an Investigational Device Exemption (IDE) in the same RA patient population that seek to assess safety as well as effectiveness of the Galvani platform. Patients can currently enrol in Dallas, New York, Austin, Anniston and surrounding areas.
“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,” said Roy Fleischmann, lead investigator for the US study and clinical professor of Medicine at the University of Texas Southwestern Medical Center in Dallas, USA.
The Galvani platform is currently available for investigational use only and is not approved for use outside of clinical studies. The release also notes that “actual results may differ materially from anticipated results”.
