Abstract

not-yet-known not-yet-known not-yet-known unknown Aim: The incidence of osteoporosis is projected to exceed 70 million people over the age of 65 by 2030. Osteoanabolic agents, like teriparatide and abaloparatide, are not only effective in reducing fracture incidence but also improve skeletal microstructure; an important challenge not met by antiresorptive agents. However, anabolic agents must be administered by daily subcutaneous injections which can be a challenge in older women. To address this need, we have developed an oral robotic pill (RP) designed to deliver biotherapeutics safely and painlessly. Methods: This report describes the results of a two-part Phase 1 study conducted to evaluate the safety, tolerability and pharmacokinetics (PK) of single (Part 1) and repeat doses (Part 2) of teriparatide delivered via the RP (RT-102) in healthy and post-menopausal women. Results: All participants were able to swallow RT-102 without any difficulty. Teriparatide, administered by the RP, was measurable in the circulation of 90% (26/29) and 91% (63/69) of participants in Part 1 and Part 2, respectively. Doses of teriparatide administered via RP yielded higher estimated bioavailability than SC. RT-102 was well tolerated without any SAEs. Drug-related adverse events were similar in severity and frequency between RT-102 and teriparatide SC. Conclusion: These data demonstrate that RT-102 can safely and reliably deliver therapeutic levels of teriparatide.