• Successful implantation and treatment underway in world’s first patient receiving experimental therapy for Rheumatoid Arthritis (RA) using splenic nerve stimulation 
• Electrical stimulation of nerves specific to visceral organs potentially a new treatment class in auto-immune and other diseases.
• Laparoscopically implanted and wirelessly controlled bioelectronics platform delivering the treatment having broad further therapy utility  

SAN FRANCISCO, Calif., January 27, 2022 (BUSINESSWIRE) - Galvani Bioelectronics, a clinical-stage company formed through a strategic partnership between GlaxoSmithKline (GSK) and Verily Life Sciences (Verily) in 2016 with the aim to develop targeted neuromodulation therapies, today announced that the first patient with Rheumatoid Arthritis (RA) has been treated through stimulation of the splenic nerve using its novel bioelectronics platform. The 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.   

Therapy initiation took place over the last month as part of a small clinical study at the NHS Greater Glasgow & Clyde Health Board, Scotland, marking the first time Galvani has studied its investigational 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. 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, Chief Medical Officer of Galvani Bioelectronics.

The primary purpose of this feasibility study, approved by the UK’s 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 anti-rheumatic drugs. 

“Splenic nerve stimulation represents a novel and likely complementary approach for the treatment of autoimmune diseases,” said Dr 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. 

Splenic nerve stimulation generates nerve signals to the spleen which in turn 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, 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 centered around the world’s first fully laparoscopically implanted neurostimulator. 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.