Emisphere Technologies, Inc announced that Novartis Pharma AG has initiated a second phase-I trial for an oral PTH1-34 which uses Emisphere's Eligen Technology, and is in development for the treatment of postmenopausal osteoporosis. Emisphere Technologies is a biopharmaceutical company that focuses on a unique and improved delivery of pharmaceutical compounds and nutritional supplements using its Eligen Technology.

The study is a partially blinded, placebo controlled, active comparator study to explore the safety, tolerability, pharmacokinetics and pharmacodynamics in postmenopausal women after daily oral doses of PTH1-34.

The study has two parts (A and B) and will enroll a total of approximately up to 120 postmenopausal women. In Part A of the trial, ascending doses of oral PTH1-34 using the Eligen Technology will be tested for safety, tolerability and pharmacokinetics and compared to Forsteo. In Part B, in addition to safety and tolerability of oral PTH1-34 using the Eligen Technology, pharmacodynamic responses will be measured by bone biomarker levels and bone mineral density, and compared to Forsteo. First patient enrollment is planned in April.

Commenting on this, Michael V Novinski, president and chief executive officer of Emisphere, stated, "We are pleased to announce the initiation of a second phase-1 trial for oral PTH1-34 using our Eligen Technology, sponsored by Novartis. The successful development of a safe and effective oral formulation of PTH1-34 will be a welcome option for a large number of patients for whom injection is the only currently available therapy."

Emisphere is a biopharmaceutical company that focuses on a unique and improved delivery of pharmaceutical compounds and nutritional supplements using its EligenÒ Technology.