Galvani Bioelectronics Announces Clinical Progression of Its Therapy Platform and Addition of New Chief Medical Officer
17 Julio 2024 - 3:19PM
Business Wire
- 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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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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