Study results of PTH1-34 oral parathyroid hormone presented

Oct 22 2009

Emisphere Technologies, Inc. (OTC BB:EMIS) today announced study results demonstrating that a single dose of the novel oral parathyroid hormone PTH1-34, which utilizes Emisphere’s proprietary Eligen^® Drug Delivery Technology and absorption-enhancer carrier molecule 5-CNAC, achieved potentially therapeutically relevant exposure and safety profiles to those of the currently available injectable formulation in healthy postmenopausal women. The results, from a single-center, partially blinded, incomplete cross-over study conducted by Emisphere’s partner Novartis Pharma AG, were presented Monday, October 19, 2009 in a poster session at the 73^rd Annual Scientific Meeting of the American College of Rheumatology in Philadelphia.

This 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, 20 μg of subcutaneously injected parathyroid hormone PTH1-34 (Forteo^®), or one of several orally administered doses of PTH1-34 formulated with either 100 or 200 mg 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 5 mg doses of oral PTH1-34 containing 200 mg 5-CNAC achieved exposure levels closest to those of 20 μg injectable PTH1-34, with a comparable incidence of adverse events. Ionized calcium remained within normal limits in all treatment groups.

“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,” said Michael V. Novinski, President and Chief Executive Officer, Emisphere Technologies. “We look forward to continuing clinical development of PTH with the Eligen^® Drug Delivery Technology.”

There were no serious adverse events in the study. Nine participants withdrew from the study due to treatment-related AEs. Of those, five (one on placebo, one on Forteo^® and three on either 2.5 or 5 mg PTH1-34) withdrew because of symptomatic hypotension. Three patients on either 2.5 or 5 mg PTH1-34 withdrew because of delayed vomiting. One patient on 2.5mg PTH1-34 (100 mg 5-CNAC) withdrew because of symptomatic, but unconfirmed, hypercalcemia.