SAN FRANCISCO– 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.
“The Galvani bioelectronics platform potentially brings a new way to shift the balance from disease to healthy states in a range of immune-mediated and other diseases,” said Dr Kristoffer Famm, President of Galvani Bioelectronics.
“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,” said Stephen Gillett, President and COO of Verily and Galvani Board Director.
In parallel with the UK study, Galvani Bioelectronics has also initiated a larger US-based randomised and double-blinded feasibility study, approved by the U.S. 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 enroll 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 Dr Roy Fleischmann, lead investigator for the US study and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center at Dallas. (Dr Fleischmann is Co-Medical Director of the Metroplex Clinical Research Center in Dallas.)
“The first patient receiving experimental therapy is an important milestone for this potential new treatment. 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,” said Christopher Corsico, Senior Vice President, Development, GSK and Chairman of the Galvani Board.
