MicroCHIPS, developer of implantable drug delivery system, starts first clinical trial in humans

A dozen years after it was founded, the MIT spin-out MicroCHIPS has finally started testing its implantable drug delivery system in humans. MicroCHIPS CEO Ajit Gill tells me the company began the study last month in Denmark, implanting its small, subcutaneous device in eight women suffering from osteoporosis.

The MicroCHIPS device, pictured at right, will be delivering a drug called Forteo, made by Eli Lilly & Co. and used to increase bone density in patients suffering from severe osteoporosis. Currently, women who take the drug need to give themselves daily injections. Eventually, MicroCHIPS aims to market a device that could deliver the drug for about a year — no needle pokes required. (Most patients on Forteo, a synthetic version of parathyroid hormone, take it for about two years, Gill says.) The implant can be done in a doctor's office with just local anesthetic, says Gill, who joined MicroCHIPS last spring.

The MicroCHIPS device holds tiny doses of a drug inside reservoirs that can pop open on a pre-programmed schedule, or as a doctor deems necessary, triggering releases with a handheld wireless device. (A small pulse of electricity melts a layer of titanium and platinum that seals the top of each reservoir.) This first study in humans will look at how the osteoporosis drug circulates in patients' bodies once it is released.

MicroCHIPS sprang from MIT research done by professors Bob Langer, Michael Cima, and a PhD student of theirs, John Santini, who served as the company's CEO until last year. Early last year, Santini told me that the company had raised more than $70 million to develop its implant, much of it from Polaris Venture Partners in Waltham, Flybridge Capital Partners in Boston, and corporate investors like Medtronic and Novartis.

But Gill tells me the company has shrunk to just four employees, and is using a contractor to oversee the current clinical trial. (He says MicroCHIPS had about twenty employees when he arrived last April.)

Why did it take the company so long to get its device into humans? Gill says that keeping moisture out of the device proved a big headache: "Proteins and peptides are really sensitive to moisture, and hermetically sealing it turned out to be challenging."

MIT professor Langer says that a lot of money was spent exploring whether the device should be used to dispense drugs, or hold an array of sensors that could be exposed to the body over time to detect things like blood sugar level. "Money and time were split between those two ideas," he says. More issues the start-up faced: "Accurately loading and dosing the drug [onto the chip], and formulation and drug stability," Langer says. "It's a totally new kind of technology, and that's both good and bad."

The device that MicroCHIPS is currently testing has just 20 reservoirs that hold individual doses of a drug, but Gill says the product that the company plans to market will have 400 reservoirs. "Our next step will be developing that commercial device and putting it through tests," he says.

Gill says the company has also been exploring using its technology to deliver various multiple sclerosis drugs, and glucagon, a drug used to raise blood sugar levels in diabetics.

And Gill adds that the company will likely need to raise even more money to win FDA approval for its device. Some of that money, he suggests, could come from corporate partners.