Waltham, MA-based MicroCHIPS announced today that its lead product—an implantable, wireless, chip-based device that delivers a drug to treat the bone disease osteoporosis—performed well in its first human trial. The study, published in the online edition of the journal Science Translational Medicine, showed that post-menopausal women who received daily doses of the popular drug teriparatide (Forteo) via the device absorbed the same therapeutic levels as generally observed in women getting daily injections.
The company hailed the results as validation of its original mission—to design a device that would make it easier for patients to comply with drug regimens that are vital to their long-term health, but are a major hassle because they require frequent pills or injections. “A key finding was that patients found our implant acceptable—they couldn’t feel it in their bodies,” says chief operating officer Robert Farra (pictured above). “This minimizes the burden on the patient of having to manage this disease.”
When Xconomy first profiled MicroCHIPS in 2007, the company’s founders—which included MIT professor (and Xconomist) Robert Langer—hoped to make a big impact on the medical devices industry with a technology it invented to encase drugs in tiny reservoirs laid out on a chip that can be controlled wirelessly. The company raised $33 million in three rounds of venture financing, went through a few twists and turns in its strategy, and then settled on osteoporosis as its lead pursuit.
MicroCHIPS’s device is roughly three-by-five centimeters—the size of a USB flash memory stick—and can be implanted in patients during a 30-minute outpatient procedure. The device can be programmed to release a single dose each day, at a specific time. Furthermore, says Farra, “it keeps a log of each dose, which a physician can upload anytime to make sure it’s working properly. We can also change the dosing schedule at any time.”
Robert Neer, founder and director of the Bone Density Center at Massachusetts General Hospital and a member of MicroCHIPS’s scientific advisory board, says an alternative to pills and injections is sorely needed in the field of osteoporosis, where a huge proportion of patients fail to stick with prescribed therapies. “The problem with osteoporosis is it doesn’t cause symptoms untilyou have a fracture,” Neer says. So some patients forget to take their drugs, or just assume they don’t need to take them because they feel okay, he says. “It’s kind of like termites—you don’t realize anything’s wrong until something collapses.”
Patients in the trial received teriparatide through the MicroCHIPS device for one month. During the study, changes in blood calcium and other biological markers of bone strengthening proved similar to those that were shown in previous studies of women taking daily injections. Farra says MicroCHIPS will spend the next two years or so making a chip that can hold 365 doses of the osteoporosis drug and getting it ready for longer-term trials, which he hopes to initiate in 2014.
Designing the osteoporosis drug/device combo was far from easy. Neer, who has advised MicroCHIPS for the past 10 years, says it was a challenge for the company to devise a formulation of the drug that would remain stable for up to a year, and that would diffuse properly from the tiny reservoirs on the chip. Furthermore, the device had to be waterproof so it wouldn’t be destroyed by the natural liquids in the body. “They had to figure out how to make it water-tight, but without welding it at a high temperature, ” he recalls, because that would have endangered the stability of the drug.
Still, MicroCHIPS’s biggest challenges may lie ahead. The FDA has not yet advised the company on the scope of future trials, but Neer predicts the agency will require at least one study that goes on for two years. And there’s a small chance the FDA will also ask the company to do a “fracture-prevention” trial to show the device is at least as good as currently marketed products at fending off dangerous fractures. Such a study, Neer says, “would require testing it in several thousand patients over several years.”
Should the company survive a rigorous trial process, it will likely face some marketing challenges as it tries to persuade physicians to replace easy-to-prescribe drugs with something that has to be implanted. “The company will need to show the treatment is as effective or more effective than pills or injections,” Neer says. “If they can show it improves bone density better than any injection, that will impress doctors.”
MicroCHIPS has a syndicate of investors that includes InterWest Partners, Polaris Venture Partners, Novartis Venture Fund, Flybridge Capital Partners, Medtronic, Saints Capital, Intersouth Partners, Care Capital, and CSK Venture Capital. Farra says all the investors have “expressed continued support” but that the company is currently looking for further funding and possible partnerships.
As for the challenge of convincing the FDA—and ultimately doctors and patients—that an implanted device is the way to go in osteoporosis, Farra isn’t worried. “Only 25 percent of people who start Forteo complete all 24 months of treatment,” he says. “This implant is sensible—it will allow physicians to give their patients the full benefit of treatment.”