SetPoint Medical is trying to use tiny pulses of electricity to treat inflammation in the body, and it now has an additional $30 million in funding to continue testing its approach in humans.
The capital infusion announced Monday for SetPoint is a Series D round of investment. The company says it plans to use the funding to advance its bioelectric therapy into Phase 2 clinical trials in patients who have rheumatoid arthritis.
SetPoint was the first investment of Action Potential Venture Capital, a $50 million fund that drug giant GlaxoSmithKline (NYSE: GSK) founded in 2013 to invest in startups developing “bioelectronic medicine”—therapies that treat disease by targeting the electrical signals carried by nerves. SetPoint delivers its doses of electricity via a tiny implantable bioelectronic device. The company says its device sends signals to the vagus nerve, which in turn dampens the symptoms of inflammation experienced by patients who have rheumatoid arthritis (RA), an autoimmune condition characterized by chronic joint swelling and stiffness.
Treatments for RA include anti-inflammatory drugs or treatments that suppress the immune system. While new RA drugs have advanced through clinical trials, some companies have run into obstacles. Eli Lilly’s (NYSE: LLY) RA treatment baricitinib has been approved in Europe, but the FDA rejected it in April, citing safety concerns. That delay has set back the Indianapolis company’s U.S. plans for the drug by at least 18 months. Meanwhile, an advisory committee to the FDA cited safety concerns in recommending not approving the RA drug sirukumab (Plivensia), a biological RA therapy developed by Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech. An FDA decision on the drug is expected by late September.
David Chernoff, chief medical officer of SetPoint, said in a prepared statement that biological RA drugs are expensive, don’t work for all patients, and can cause severe side effects. He said bioelectronic treatment could offer an alternative to drug therapy.
Last summer, SetPoint published data from a Phase 1 clinical trial that showed its device mitigated the inflammatory symptoms of RA. The 12-week study enrolled 17 RA patients, several of whom had not responded to other treatments. The company said that stimulating the vagus nerve with electric current inhibited the production of a protein associated with inflammation. The company added that no serious adverse effects from the device were reported.
According to records SetPoint filed on clinicaltrials.gov, the Phase 2 trial will extend the earlier study; patients who completed the Phase 1 trial will now be tested over 12 to 18 months.
SetPoint says the latest round of funding came from investors who had already put money into the company, including New Enterprise Associates (NEA), Morgenthaler Ventures, Medtronic (NYSE: MDT), Boston Scientific (NYSE: BSX), Topspin Partners, and Action Potential Venture Capital, among others. In March, SetPoint announced that NEA had joined as an investor, though the company did not disclose any financial terms at the time.
Besides treating RA, SetPoint says that electrical stimulation of the vagus nerve offers potential for treating Crohn’s disease, an inflammatory bowel disease.
Photo by SetPoint Medical.