Biotech and Pharma

GlaxoSmithKline's big bet on electroceuticals

A few years ago, Moncef Slaoui, then GlaxoSmithKline's head of research, challenged his team to come up with a new pillar of medicine.

The British drugmaker already makes traditional small-molecule pills and biologic therapies made with living cells, and it sells vaccines and consumer products. One area not yet tapped by medicine? The electrical signals that govern many of the functions in our bodies.

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By better understanding our bodies' electrical systems, GSK hopes to design technology small and smart enough to manipulate them and possibly conquer diseases from rheumatoid arthritis to asthma to diabetes.

"If we look 10 years out, we should have a number of tiny devices—we call them bioelectronic medicines, because they are medicines—that will be treating conditions we use molecular medicines for today," Kris Famm, head of GSK's bioelectronics research and development unit, said in a telephone interview. "We are quite convinced this can be a class of new therapies."

The technology GSK envisions, which is also known as electroceuticals, would involve implanting tiny devices on nerve bundles associated with specific organ functions. Its broadest applications are still years from the market, but Famm said he thinks the biology is becoming well-enough understood that the challenge becomes one of engineering: being able to miniaturize electronic devices enough to very specifically stimulate certain nerves, and do so in an autonomous way, detecting and reacting to problems in the body. The approach should be so specific it avoids the off-target side effects that can derail otherwise promising medicines, he said.

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GSK has invested $50 million in its venture arm to go to start-ups in bioelectronics, and has forged 40 research collaborations with universities and companies, Famm said. It's also started a $1 million contest for bioelectronics research, with the prize going to scientists who create an implantable device "that can read and write the body's electrical language."

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Of course, the idea of using implantable electronic devices isn't totally novel, said Kip Ludwig, program director of neural engineering at the National Institutes of Health. The pacemaker is an obvious early example, though GSK's Famm points out it stimulates the heart muscle, rather than nerves.

"The idea's been around since the late 1800s," Ludwig said. "They're already here. They've already, in many cases, shown clinical efficacy in blinded, randomized, sham-controlled studies, and gotten FDA approval."

Interrupting hunger signals

He cited a technology made by EnteroMedics, approved by the Food and Drug Administration in January for treatment of obesity. The company calls it the Maestro System, and says it's a "pacemaker-like device" implanted to block signals along the nerves connecting the brain and stomach, helping people feel less hungry.

In a clinical trial, patients with the technology lost about 10 percent of their total body weight after 18 months, compared with 4 percent total body weight loss for those in a control arm, EnteroMedics reported in December 2013.

Ludwig also cited cochlear implants for hearing and deep brain stimulation for Parkinson's disease as other examples.

"But we actually know relatively little about the biology of how these work, which means they can get a lot better," Ludwig said. "They're devices, and right now surgical procedures have risks associated with them, but you can easily see these devices getting really small and really smart."

US specialty drug spending trends in 2015
US specialty drug spending trends in 2015

That's GSK's goal, and recent years have seen an increased focus on the area from other sources than the British drugmaker. The NIH has dedicated about $250 million in funding to map the neural circuitry of our organs to better understand how it might be targeted to treat disease; the program is called SPARC, for Stimulating Peripheral Activity to Relieve Conditions.

At GSK, Famm compares the potential of bioelectronics in medicine to what Apple did for telephones.

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"With the risk of sounding a bit too bullish here, what we're trying to do is basically redefine neuromodulation," he said. "When Apple decided mobile phones existed but the potential of them hasn't really been tapped, obviously the iPhone did just that. I think we have the same underlying potential ... it could be a revolution."

Investors and analysts say GSK needs a boost. Jefferies analyst Jeffrey Holford named the British drugmaker one of his least preferred global pharma stocks in a research note Tuesday, citing a "lack of catalysts and guidance for 2015."

"GSK is one of the last pharmas to really announce its strategy," said Les Funtleyder, portfolio manager with E Squared Asset Management. The company's stock has declined 18 percent in the last 12 months, compared with an increase of 9.6 percent for the , as prices for its asthma drugs came under pressure in the U.S. and Europe.

Thinking differently

"Of course that said, if they want to be the guys to do cool projects or develop very game-change products, that could be their strategy," Funtleyder said. "This is very interesting."

GSK's Slaoui, now chairman of global vaccines and a member of the drugmaker's board, is known for thinking differently.

"Moncef has always been someone who can think out-of-the-box and see the value at the nexus of disciplines," Stelios Papadopoulos, chairman of biotechnology companies Biogen Idec, Exelixis and Regulus Therapeutics, wrote in an email. "I have followed with interest the field of electroceuticals since he and his colleagues at GSK described their ideas in Nature in April 2013 and I think their ideas are very exciting."

It could be a decade before many bioelectronic medicines are in use, Famm said. And much of the technology still needs to be worked out, including power sources, according to Ludwig—who envisions wirelessly rechargeable batteries that can last 10 to 20 years.

"It's very early," Funtleyder said. "But if these guys don't take a chance on moonshots, we're never going to get anywhere."