Unigene initiates oral PTH Phase 2 study in postmenopausal women with osteoporosis

Mar 16 2011

Unigene Laboratories, Inc. (OTCBB: UGNE) a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced today the dosing of the first subject in a Phase 2 study with an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women. Unigene is developing its oral PTH in collaboration with GlaxoSmithKline (GSK) as part of an exclusive worldwide licensing agreement

Ashleigh Palmer, President and Chief Executive Officer of Unigene Laboratories, Inc., said, "The initiation of this oral PTH Phase 2 study with our proprietary oral formulation of the recombinantly produced PTH analog is a major accomplishment for Unigene, and we are thrilled with the significant progress we have made advancing this program over the past nine months. Palmer added, "We are extremely grateful to our partner for its continued support and hope, through the results of this study, to be providing GSK with a compelling basis for electing to proceed with the next stages of development."

Phase 2 Study Design

This multicenter, double blind with respect to placebo, randomized, repeat dose placebo controlled study will include an open label comparator arm of the Forsteo® injectable formulation. The primary endpoint will be an increase in bone mineral density (BMD) at the lumbar spine in subjects at 24 weeks in 93 postmenopausal osteoporotic women following once daily treatment with the orally delivered PTH analog compared to baseline. Secondary endpoints will evaluate biochemical markers of bone formation and resorption, as well as the safety, tolerability and pharmacokinetics of the oral formulation.

Patient enrollment for this study is ongoing and expected to be completed in the first half of 2011. The Company expects to report top-line results before year end.