Tarsa Therapeutics, a licensee of peptide-based therapeutics company Unigene Laboratories, today reported the conclusion of a phase 2 trial of its oral recombinant salmon calcitonin for the prevention of postmenopausal osteoporosis. Results of the study show the oral calcitonin tablet as statistically significant, demonstrating clinically relevant improvements in bone mineral density (BMD) at the lumbar spine.
The phase 2 trial evaluated the ability, safety, and efficacy of the oral calcitonin tablet to improve BMD at the lumbar spine after one year of daily treatment in patients with low bone mass (osteopenia) at increased risk of fracture. In this study, oral calcitonin was reported as superior to placebo in increasing BMD at the lumbar spine in this patient population; the tablet’s safety profile did not substantially differ from that of placebo.
“We are delighted with the positive results from Tarsa’s study of oral calcitonin in postmenopausal women with osteopenia,” Ashleigh Palmer, Unigene CEO, stated in the press release. “The safety and efficacy data in this phase 2 study confirm the positive results that Tarsa achieved in its phase 3 study of oral calcitonin for the treatment of postmenopausal osteoporosis.”
The company also reports that the phase 2 study results were the subject of an oral presentation at the American Society for Bone and Mineral Research (ASBMR) 2012 Annual Meeting.
For more information visit www.unigene.com
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