First-in-human testing of a wirelessly controlled drug delivery microchip

Area of Science:

• Biomedical Engineering
• Endocrinology
• Pharmacology

Background:

• Osteoporosis treatment with human parathyroid hormone fragment (1-34) [hPTH(1-34)] is effective but hindered by daily injection compliance issues.
• Achieving optimal bone mineral density requires pulsatile hPTH(1-34) delivery, posing a challenge for existing drug delivery systems.

Purpose of the Study:

• To evaluate the safety, efficacy, and pharmacokinetics of an implantable microchip device for delivering hPTH(1-34) in postmenopausal women with osteoporosis.

Main Methods:

• Eight osteoporotic postmenopausal women received implanted microchip devices containing lyophilized hPTH(1-34).
• Devices were wirelessly programmed for daily drug release over 20 days, with subsequent hPTH(1-34) injections for comparison.
• Pharmacokinetics, safety, tolerability, and bone markers were assessed.

Main Results:

• Device-based hPTH(1-34) delivery demonstrated comparable pharmacokinetics to injections with reduced variability.
• Daily release from the microchip device led to increased bone formation markers.
• The implantable device and drug were well-tolerated, with no adverse events reported.

Conclusions:

• Implantable microchip technology provides a viable, safe, and effective alternative for pulsatile hPTH(1-34) delivery in osteoporosis management.
• This innovation addresses patient compliance challenges associated with daily injections, potentially improving treatment outcomes.