- FDA approves progression of Galvani's splenic neuromodulation therapy to the randomized, controlled stage of clinical feasibility testing in rheumatoid arthritis after review of initial patient safety and effectiveness.
- Dr. Raolat Abdulai is joining Galvani as Chief Medical Officer to spearhead the company's clinical pursuit of its splenic therapy and wider therapy platform.
Galvani Bioelectronics, a clinical-stage therapeutics company formed through a strategic partnership between GSK and Verily Life Sciences to develop targeted neuromodulation therapies, today announced it is recruiting the randomized, controlled stage of a clinical feasibility study for patients with Rheumatoid Arthritis (RA). This progression has been approved by the US Food and Drug Administration (FDA) following review of safety and initial effectiveness from a first group of patients.
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Picture of Dr. Raolat Abdulai (Photo: Business Wire)
Patients with active RA who have had inadequate response to multiple prior targeted therapies can enroll in the study in multiple areas in the US including New York City (NY), Dallas-Fort Worth (TX), Austin (TX), San Antonio (TX), Los Angeles (CA), Portland (OR), Altoona (PA), and Hagerstown (MD) as well as in Amsterdam and Eindhoven in the Netherlands.
The investigational treatment is the first in the clinic to directly stimulate the splenic nerve and Galvani's therapeutic platform is the first to electrically stimulate nerves specific to individual visceral organs central in disease.
To lead clinical development on the back of this positive initial clinical readout, Dr. Raolat Abdulai will join the company as Chief Medical Officer in August. Dr. Abdulai joins from Sanofi where she was global clinical lead for the development of Dupixent (dupilumab) across multiple indications, including a recent first approval for a biologic in COPD in the EU.
"I'm delighted to welcome Raolat. She brings great leadership, deep expertise, and critical experience in developing transformational immunology therapies. This comes at a pivotal time for the clinical development of the full potential of our lead therapy and wider therapy platform," said Dr. Kris Famm, President and CEO of Galvani.
"I am thrilled to be joining Galvani at this critical point. The company's platform has the potential to revolutionize the way we treat disease. I look forward to working with Kris and the Galvani team to bring this technology to patients," said Dr. Abdulai.
About splenic neuromodulation
Targeted splenic nerve stimulation directly generates nerve signals to the spleen which have been shown preclinically to shift immune cells there from pro-inflammation to inflammation-resolving states1,2. The immune cells may then, as they circulate, reach sites of injury in disease, for example the joints in RA. The clinical studies underway investigate whether this will lead to the reduction or resolution of the inflammation and associated pain for patients, as has been seen preclinically3
To learn more about splenic nerve stimulation for RA, visit https://www.consideraterastudy.com/ and NCT05003310 (US NL) or NCT04955899 (UK NL).
About Galvani's therapy platform
Resulting from a major research and development effort over the last seven years, the Galvani Bioelectronics platform is centered around the world's first minimally invasively 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 is available for investigational use only and is not approved for use outside of clinical studies. Actual results may differ materially from anticipated results.
About Galvani Bioelectronics
Galvani Bioelectronics is a pioneering research and development company dedicated to bringing bioelectronic therapies to patients. The company was formed through a partnership between two global healthcare companies, GSK and Verily Life Sciences, a subsidiary of Alphabet Inc. Galvani is developing therapies through implant-based direct modulation of specific neural signals to organs central in disease. These therapies are designed to be safe, precise in their therapeutic effect, and minimally invasive in their delivery through use of small and efficient wireless electronics and keyhole surgery. Connected software will ensure that patients and physicians can effectively control and optimize the therapy. For more information, visit www.galvani.bio.
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1 Donegà, M. et al. Human-relevant near-organ neuromodulation of the immune system via the splenic nerve. Proc. Natl. Acad. Sci. U. S. A. 118, (2021)
2 Sokal, D. M. et al. Splenic Nerve Neuromodulation Reduces Inflammation and Promotes Resolution in Chronically Implanted Pigs. Front. Immunol. 12, 649786 (2021)
3 Guyot, M. et al. Apical splenic nerve electrical stimulation discloses an anti-inflammatory pathway relying on adrenergic and nicotinic receptors in myeloid cells. Brain Behav. Immun. 80, 238-246 (2019)
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