Emisphere Technologies has reported that a single dose of the novel oral parathyroid hormone PTH1-34 has achieved potentially therapeutically relevant exposure and safety profiles to those of the currently available injectable formulation in healthy postmenopausal women. Reportedly, it utilizes Emisphere’s proprietary Eligen Drug Delivery Technology and absorption-enhancer carrier molecule 5-CNAC.
The phase I single-center partially blinded incomplete cross-over, designed to assess the exposure and safety of orally administered doses of PTH1-34 and different amounts of the absorption enhancer 5-CNAC was conducted in 32 healthy postmenopausal women.
The subjects were randomized to receive a single dose of placebo, 20g of subcutaneously injected parathyroid hormone PTH1-34 (Forteo), or one of several orally administered doses of PTH1-34 formulated with either 100 or 200mg of Emisphere’s absorption-enhancer 5-CNAC. While all doses of oral PTH1-34 were rapidly absorbed and showed appreciable blood concentrations in a dose-dependent manner, the 2.5 and 5mg doses of oral PTH1-34 containing 200mg 5-CNAC achieved exposure levels closest to those of 20g injectable PTH1-34, with a comparable incidence of adverse events. Ionized calcium remained within normal limits in all treatment groups.
Michael Novinski, president and CEO of Emisphere Technologies, said: We are pleased with the outcome of our study. It indicates we may be able to provide women with postmenopausal osteoporosis a more convenient oral option for parathyroid hormone therapy, which is now available only as an injection. We look forward to continuing clinical development of PTH with the Eligen Drug Delivery Technology.
