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news.Unigene Laboratories has dosed the first subject in a multicentre, double blind, randomised, repeat dose placebo controlled Phase II study evaluating an experimental oral parathyroid hormone (PTH) analog as a treatment for osteoporosis in postmenopausal women.
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Patient enrollment is expected to be completed in the first half of 2011 and the company expects to report top-line results before year end.
Unigene is developing its oral PTH in partnership with GlaxoSmithKline (GSK) as part of an exclusive worldwide licensing agreement.
The 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 (BMD) at the lumbar spine at 24 weeks in patients following once daily treatment with the orally delivered PTH analog 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.