Galvani Bioelectronics, a newly established company launched by GlaxoSmithKline (GSK) and Verily Life Sciences (formerly Google Life Sciences), will explore a new wave of science. Galvani Bioelectronics will focus on the development of bioelectronic medicine: the use of implantable devices to modify the electrical signals that nerve cells use to communicate within the body.

In chronic diseases, these signals may be irregular or they may communicate incorrect information or instructions. The devices under development will be able to correct these signals using an electrical impulse.

This field of medicine has the potential to impact the treatment of chronic diseases such as asthma, arthritis and hypertension. The initial venture of the new company will be to solidify clinical proofs-of-principle and to develop miniature devices that can be applied to the treatment of endocrine disorders such as type 2 diabetes. Its research also encompasses inflammatory disorders, such as inflammatory bowel disease, and metabolic conditions.

The miniature devices under development will attach to, or sit next to, individual nerves, which will allow clinicians and researchers to influence the very communication system that the human brain uses to regulate and influence its target organs.

Mary Anne Rhyne, director of External Communications at GSK, said, “Bioelectronic medicines represent a whole new frontier in the treatment of disease.”

The goal is to develop implantable devices about the size of a grain of rice capable of emitting appropriate impulses. Kris Famm, vice president of Bioelectronics R&D at GSK, said, “The primary function will be therapeutic—a ‘correct’ function—and indeed some of the first-generation devices may only have a ‘correct’ function. That said, the medium- to long-term ambition is … [to] have a ‘detect’ function as well as a ‘correct’ function.”

Not only is this a potentially tremendous advancement on its own, but the new technology may be able to be used in conjunction with drugs and vaccines. Some postulate that bioelectronic medicine could perhaps obviate the need for traditional pills and injections.

Famm highlights the fact that bioelectricity is not a new concept: “It can, of course, be game-changing in terms of how we treat disease, but it’s leveraging something in biology that has been there all along. The body has used the peripheral nerves to control, with precision and speed, many processes. So in that sense, it’s not science fiction, it’s science fact.”

Rhyne said, “Unlike more traditional areas of science, bioelectronics requires the combined skills of world-leading biologists, engineers, neuroscientists and IT experts. This new company will give us the ability to significantly accelerate our research in this field. The formation of Galvani Bioelectronics tightly integrates scientists, engineers and clinicians around the singular, energizing mission of discovering and developing bioelectronic medicines. Huge advances in low-power electronics and the nanotechnology space have paved the way for the creation of game-changing miniaturized devices, which we believe will enable the development of precision bioelectronic medicines.”

The first human applications could be ready for approval in the next 10 years, but Galvani Bioelectronics has goals that are much closer. According to Rhyne, “We plan to demonstrate clinical proof-of-concept with an experimental device in three disease indications in the next three years.”

The goal of bioelectronic treatment is to target specific organs and thereby reduce or avoid the unwanted side effects of drugs that course through the bloodstream, exposing every cell of the body to a medication intended for one specific purpose. As far as what this means to the clinical trial industry, translating electronic devices into biologically safe and usable implants is a challenge requiring ongoing research. Only a few preliminary trials have used bioelectronics in human subjects, and there is still much to be learned. On the path to approval for these new devices, many experimental trials lie ahead.

Famm does not anticipate that bioelectronics will significantly take away from drug trials, but rather sees this as an additional modality, just as the body uses both electrical impulses (nerves) and molecular messages (hormones) to communicate its messages. The trials themselves have the potential to be quite interesting. Said Famm, “Clinical development will be very data-rich, with the opportunity for adaptive trials.”

Famm said, “We at GSK … have worked over the last three years to identify a number of diseases where we show an animal proof-of-principle. On the Verily side, they have developed technology that allows the building of the hardware and software for these (miniaturized) devices. If they come together, they actually get you to the therapies, and that is the fundamental reason why you see the formation of this company.”

On the impact of Galvani Bioelectronics’ future work, Famm notes, “Neuromodulation has existed for a long time, but (the existing companies) have not really explored the opportunity that we see for chronic disease, centered on visceral organs and the nerves that are associated with them. Nor have they really ‘pushed the boat out’ in terms of making really miniaturized devices that can be deployed in those anatomies. So we are targeting a new space.”

The technology is too new for many experts in clinical research to feel comfortable commenting on. The label “science fiction” has surfaced from more than one direction. Ultimately, the primary feelings agreed upon by industry is that everyone will follow bioelectronics development.  

This article was reprinted from Volume 20, Issue 31, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »