Unigene Initiates Osteoporosis Drug Study

The study will enroll 93 postmenopausal osteoporotic women and will include an open label comparator arm of Forsteo injectable formulation.

Unigene Laboratories has dosed the first subject in a Phase II study evaluating an experimental oral parathyroid hormone analogue as a treatment for osteoporosis in postmenopausal women. Patient enrolment is expected to be completed in the first half of 2011 and the company expects to report top-line results before the end of the year.

Unigene is developing the drug in partnership with GlaxoSmithKline, as part of an exclusive worldwide licensing agreement.

The multicentre, double blind, randomised, repeat-dose and placebo-controlled study will enroll 93 postmenopausal osteoporotic women and will include an open label comparator arm of Forsteo injectable formulation.