Implantable microchip-based drug delivery device musculoskeletal data

A Danish study in 7 postmenopausal women with osteoporosis aged 65-70 showed that 40 µg teriparatide administered daily via MicroChips' implantable microchip-based drug delivery device for up to 20 days had a comparable PK profile to that of subcutaneous injections of 40 µg teriparatide. Additionally, MicroChips said that changes in levels of serum calcium and 2 biomarkers of bone turnover - procollagen type I N-propeptide (PINP) and C-terminal telopeptide (CTX) - that resulted from teriparatide delivery via the implant were "qualitatively and quantitatively similar" to the changes reported from previous studies during daily subcutaneous injections of teriparatide. The company also said the microchip-based device and drug combination were biocompatible with no adverse immune reactions reported.

Patients were implanted with the wireless microchip device on day 1 after which 8 weeks were allowed to pass before drug release was initiated to ensure formation of a stable fibrous capsule around the implant. The implant then delivered up to 19 daily doses of 40 µg teriparatide during days 57-75, with the final implant dose given on day 84. Patients then received 20 µg subcutaneous teriparatide on days 91 and 96 and 40 µg subcutaneous teriparatide on days 131 and 138. The microchip was explanted on day 103. Data were published in Science Translational Medicine. MicroChips plans to submit a regulatory application for the microchip device in 2014. ...