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Galvani Bioelectronics, a clinical-stage therapeutics company resulting from a partnership between GSK and Verily Life Sciences, has initiated recruitment for the randomized, controlled phase of a clinical feasibility study targeting patients with Rheumatoid Arthritis (RA). This advancement follows FDA approval, which reviewed safety and initial effectiveness data from an initial patient cohort.
Dr. Raolat Abdulai will join Galvani as Chief Medical Officer in August, bringing extensive experience from Sanofi, where she led global clinical development for Dupixent (dupilumab), including its recent approval for COPD in the EU.
The investigational treatment marks the first clinical application of direct splenic nerve stimulation. Galvani’s platform pioneers neurostimulation tailored to visceral organ nerves, aiming to transform disease treatment paradigms. The therapy, administered via minimally invasive implantable neurostimulator, is programmable via a wirelessly connected tablet, allowing patients to monitor, control, and wirelessly charge their implants.
Current clinical studies investigate whether splenic nerve stimulation can mitigate inflammation and associated pain in RA by modulating immune cell behavior, as demonstrated in preclinical studies. Sites for enrollment include multiple locations in the US (New York City, Dallas-Fort Worth, Austin, San Antonio, Los Angeles, Portland, Altoona, Hagerstown), as well as Amsterdam and Eindhoven in the Netherlands.
Dr. Kris Famm, President and CEO of Galvani, expressed enthusiasm for Dr. Abdulai’s leadership role, emphasizing her pivotal role in advancing their therapeutic pipeline. Dr. Abdulai shared her excitement about joining Galvani and contributing to the potential transformation of disease treatment through innovative bioelectronic therapies.
Galvani’s bioelectronic platform remains investigational and is not approved for general use outside clinical trials. Actual outcomes may vary from anticipated results.
About Galvani Bioelectronics:
Galvani Bioelectronics, established through collaboration between GSK and Verily Life Sciences, is dedicated to advancing bioelectronic therapies. Their technology focuses on implant-based modulation of specific neural signals to treat diseases, ensuring safety, precision, and minimally invasive delivery using advanced wireless electronics and keyhole surgery techniques. Integrated software facilitates effective therapy control and optimization for patients and physicians alike.