MicroCHIPS, an MIT spin-out company out of Waltham, MA, has announced results of a clinical study evaluating its wirelessly controlled implantable drug releasing electronic microchip. The device features controllable reservoir arrays that can contain a drug or a microsensor. The reservoirs can be opened and closed either based on a preset program, activated wirelessly through a transmitter, or based on readings of the embedded sensors.
The current study focused on delivering teriparatide for post menopausal women suffering from osteoporosis. Normally these women would have to receive an unpleasant daily injection of the drug, but thanks to the MicroCHIPS device, they received a well controlled regular dose with little perceived discomfort.
Details from the press release:
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 resulting PK profiles from the implant were comparable to and had less variation than the PK profiles of multiple, recommended subcutaneous injections of teriparatide. 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.
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.”
To assess efficacy and improvement in bone fracture risk, the study measured biological markers of bone formation (P1NP), and bone resorption (CTX). In the study, changes in serum calcium, P1NP, and CTX resulting from drug implant therapy were found to be qualitatively and quantitatively similar to those reported in previous studies during daily subcutaneous injections of teriparatide.
“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 & Director of the Massachusetts General Hospital Bone Density Center and Associate Professor of Medicine at Harvard Medical School.
Abstract in Science Translational Medicine: First-in-Human Testing of a Wirelessly Controlled Drug Delivery Microchip