A developer of implantable drug delivery devices and biosensors announced Feb. 16 the results of a successful human clinical trial with an implantable, wirelessly controlled and programmable microchip-based drug delivery device. The company, MicroCHIPS, published it’s study in the online edition of the journal Science Translational Medicine.
"These data validate the microchip approach to multi-year drug delivery without the need for frequent injections, which can improve the management of many chronic diseases like osteoporosis where adherence to therapy is a significant problem," said study lead author Robert Farra, MicroCHIPS president and chief operating officer. "We look forward to making further progress to advance our first device toward regulatory approvals, as well as developing a range of products for use in important disease areas such as osteoporosis, cardiovascular disease, multiple sclerosis, cancer and chronic pain."
In the trial, post-menopausal women diagnosed with osteoporosis received daily doses of the marketed osteoporosis drug teriparatide through microchip delivery rather than daily injection. The drug released from the implanted microchip demonstrated similar measures of safety and therapeutic levels in blood to what is observed from standard, recommended multiple subcutaneous injections of teriparatide, according to the company.
Safety measures included evaluation of the biological response to the implant and monitoring indicators of toxicity.
The device and drug combination were found to be biocompatible with no adverse immune reaction. The resulting pharmacokinetics (PK) profiles from the implant were comparable to and had less variation than the PK profiles of multiple, recommended subcutaneous injections of teriparatide, the company said.
The study also demonstrated that the programmable implant was able to deliver the drug at scheduled intervals. Drug delivery and evaluation in patients occurred over a one-month period and provided proof-of-concept measures of drug release and device durability that support implantable device viability for 12 months or more, according to MicroCHIPS.
The microchip device was implanted and explanted using local anesthetic. Patient surveys found that the microchip device was well-tolerated, and patients indicated that they would repeat the implant procedure. "Each procedure lasted less than 30 minutes," said treating surgeon Pia Georg Jensen, MD. "The patients were able to walk out of the facility and go home unescorted."
"A microchip that continues to deliver teriparatide with this or similar consistency and efficiency over 12 to 24 months could improve bone mass, density, architecture and strength," said study co-author Robert Neer, founder and director of the Massachusetts General Hospital Bone Density Center and associate professor of medicine at Harvard Medical School.
MicroCHIPS is currently developing new designs of its microchip-based implant to include as many as 400 doses per device providing daily dosing for one year or multi-year therapy for less frequent dosing regimens. Components of the original microchip technology, such as the array of micro reservoirs used to contain drug and the first microchip opening mechanism, were developed at the Massachusetts Institute of Technology and licensed to MicroCHIPS.
The company plans to file for regulatory approval for its first microchip device in 2014.