MicroCHIPS, a developer of implantable drug delivery devices and biosensors, has announced the results of the first successful human clinical trial with an implantable, wirelessly controlled and programmable microchip-based drug delivery device. Used for osteoporosis in the clinical trial, the microchip can be used to treat other medical conditions as well.
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. In addition to osteoporosis, the company is advancing applications for the microchip device for other therapeutic applications in proprietary programs and through strategic partnerships. The company plans to file for regulatory approval for its first microchip device in 2014.
Robert Farra (President and COO, MicroCHIPS): 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.
In a 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.
In the study, seven osteoporotic postmenopausal patients between the ages of 65 and 70 received the microchip-based implant. The primary objective of the clinical trial was to assess the pharmacokinetics (PK) of the released drug teriparatide from the implanted devices. Safety measures included evaluation of the biological response to the implant and monitoring indicators of toxicity. Secondary objectives were to assess the bioactivity of the drug and to evaluate the reliability and reproducibility of releasing the drug from the device.
The device and drug combination were found to be biocompatible with no adverse immune reaction. The study also demonstrated that the programmable implant was able to deliver the drug at scheduled intervals. 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.
Implantable medical devices such as pacemakers and pain pumps perform important functions to help patients return to a healthier state and to manage their disease. The design of a next-generation microchip drug delivery device is the only approach to an implantable device that can be wirelessly programmed to release drugs inside the body without percutaneous connections in or on the patient. An implantable microchip device also provides real-time dose schedule tracking, and as part of a network, physicians can remotely adjust treatment schedules as necessary.
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.