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Date:1/9/2012

and inflammation.

Oral PTH Program Achieves Phase 2 Proof-of-Concept

On November 9, 2011, Unigene announced positive top-line results of its Phase 2 clinical study evaluating an experimental oral PTH analog for the treatment of osteoporosis in 93 postmenopausal women.  The study achieved its primary endpoint with statistical significance. The Phase 2 study was conducted by Unigene as part of a now terminated exclusive worldwide option and licensing agreement with GlaxoSmithKline (GSK). 

Unigene is actively seeking a licensing partner for the oral PTH program.

The primary objective of the Phase 2 study was to assess the change in bone mineral density (BMD) at the lumbar spine, a clinically validated predictor of fracture risk.  The study demonstrated once-daily treatment with 5mg of orally delivered PTH resulted in a statistically significant mean increase in BMD at the lumbar spine of 2.2 percent (p<0.001) at week 24 as compared to baseline. 

Secondary endpoints in the Phase 2 study evaluated an open label comparator arm of injectable Forsteo® (teriparatide), an approved treatment for osteoporosis, and placebo to assess the changes in BMD at the lumbar spine at 24 weeks.  The Forsteo® comparator arm showed a statistically significant increase in BMD compared to baseline, consistent with previously reported data.  The placebo arm showed a non-significant decline in BMD.  Safety, tolerability, pharmacokinetics (PK) and biochemical markers of bone formation and resorption were also evaluated in the study.  Positive trends in bone formation at week 24 were seen in both the oral PTH and Forsteo® arms.  Importantly, the 5mg dose of oral PTH demonstrated consistency of exposure at weeks 1 and 24 with the appropriate pulsatile PK profile.  There were no drug-related serious adverse events and no occurrences of hypercalcemia which is a common side effect of
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SOURCE Unigene Laboratories, Inc.
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