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.
Unigene is developing it’s 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.
The primary endpoint will be an increase in bone mineral density at the lumbar spine at 24 weeks in patients following once-daily treatment with the orally delivered parathyroid hormone analogue, compared to baseline.
Secondary endpoints will assess biochemical markers of bone formation and resorption, as well as the safety, tolerability and pharmacokinetics of the oral formulation.
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.