Unigene posts positive Phase 2 osteoporosis results
Unigene Laboratories (OTCBB:UGNE) has announced positive top-line results of its Phase 2 clinical study evaluating an experimental(PTH) analog for the treatment of osteoporosis in 93 postmenopausal women.
The study achieved its primary endpoint of assessing the change in bone mineral density (BMD) at the lumbar spine, a clinically validated predictor of fracture risk, with statistical significance. The Phase 2 study was conducted by Unigene as part of an exclusive worldwide option and licensing agreement with GlaxoSmithKline.
“These results further validate Unigene’s proprietary oral peptide drug delivery technology and, importantly, we have demonstrated that the oral delivery of PTH is possible, having successfully achieved proof-of-concept,” Unigene CEO Ashleigh Palmer said in a statement.
“We now believe we have the opportunity to address an important unmet medical need,” he added. “Unigene’s Peptelligence platform continues to lead the industry, and we are committed to ensuring our distinctive core competence dominates the growing peptide sector, establishing Unigene as the peptide partner of choice.”
Unigene said it will submit the Phase 2 clinical study report to Glaxo by the end of the year. GSK has up to 75 days following submission of the report to inform Unigene whether it will proceed with the clinical development of the oral formulation of a recombinantly produced PTH analog for the treatment of osteoporosis in postmenopausal women pursuant to the terms of the exclusive worldwide licensing agreement.