GlaxoSmithKline’s decision to start a $50m venture fund dedicated to bioelectric medicine – applying the principle underlying brain stimulation to the peripheral nervous system, with the intention of treating non-neurological disorders – is a significant show of support for an as-yet unproven field.
It is also a vote of confidence in California’s SetPoint Medical, which received the first cash from the fund, a $5m investment that made up part of a $27m round. SetPoint’s clinical-stage vagus nerve-stimulating technology is in trials for rheumatoid arthritis (RA), and Ralph Zitnik, its chief medical officer, says that the company is “a natural fit” with Glaxo’s ambitions.
SetPoint’s technology works by exploiting a pathway wherein stimulation of the vagus nerve causes downregulation of immune cells in the spleen such as macrophages, which release lower levels of the cytokines that cause inflammatory conditions such as RA and Crohn’s disease. “Rather than using a pill or an antibody, you can drive the body’s natural neural function to downregulate these immune cells in the spleen and other visceral organs to treat the diseases.”
Mr Zitnik tells EP Vantage that Glaxo has chosen SetPoint because it stands alone. “No one has tried to use these devices, and stimulating the nerve in this way, to treat this particular set of diseases, so we’re really unique in that sense.”
The current device SetPoint is trialling is similar to a pacemaker, Mr Zitnik says. “It is placed in the chest wall, but instead of going through the blood vessels into the heart its implanted on the neuron in the neck.”
SetPoint is also working on a second-generation stimulator that moves away from the pacemaker style. “Our [new] device is a major advance. It’s a small self-contained thing that’s about 3cm long, it’s implanted directly on the nerve, and has a self-contained rechargeable battery that uses radiofrequency magnetic induction to charge.
“When it needs to be charged, or when you need to reprogramme it, the patient puts on a collar – like a necklace – that clamps on, and this necklace communicates with the device in the neck and also with the controlling software on an iPad. That’s where our engineering vision for this device is going,” Mr Zitnik says.
This next-generation product, called a microregulator, is currently in animal studies. Human trials will start “hopefully soon”.
Part of the aim of GlaxoSmithKline’s fund, named Action Potential Venture Capital, is to ready a bioelectric technology for approval by the end of this decade. Mr Zitnik says that this goal is ambitious but achievable, and SetPoint is well on its way – especially as Glaxo is not its only investor.
SetPoint Medical’s $27m round included contributions from Covidien and Boston Scientific, as well as VCs that had already supported the firm at earlier stages, including Morgenthaler Ventures, Foundation Medical Partners and Topspin Partners.
“$27m gets us to a number of different clinical studies,” Mr Zitnik says, “as well as moving the engineering forward on our new platform. We’ve been in human studies now for a year and a half.
“I can’t really speak for how long Glaxo will take to get to registration with other devices but I can tell you that our programme is in humans in RA already. Hopefully in the next quarter or two we’ll start another pilot study in Crohn’s disease. Then our hope is to do a full-size randomised controlled multicentre study within the next year and a half to two years.”
Mr Zitnik says the company has not yet decided which indication to take to later trials. This will depend on the results from the pilot studies. “We’ll just see where this thing seems to work the best and make a decision based on that.”
Undercut the antibodies
That a pharma giant and two of the bigger medtechs – among others – are taking bioelectric medicine seriously is an indication that the technology’s time has come. The antibodies currently used to treat RA are hugely lucrative but extremely expensive and Glaxo is not a major player in this area. If vagus nerve stimulators can undercut them the companies could win.
Consequently Glaxo is going for bioelectric technologies in a big way. It set up a bioelectronics R&D unit last year and has now begun a grant programme for researchers as well as creating a network of investigators. The unit is to organise meetings around this therapy, and even plans to launch a million-dollar innovation prize.
Through Action Potential Venture Capital, the UK group intends to build a portfolio of five to seven companies over the next five years. These could be start-ups, existing companies with first-generation technologies focusing on the peripheral nervous system – SetPoint would fall into this category – and companies advancing technology platforms that will underpin these devices.
The uses to which therapeutic electric shocks are put have changed over the past 80 years, from externally delivered shocks to treat depression and schizophrenia to implanted electrodes to treat Parkinson’s disease and epilepsy. Perhaps it is not implausible that they will change further, addressing disorders that are themselves not neurological in origin.