MINNEAPOLIS, MN and PHILADELPHIA, PA – October 16, 2012 — Tarsa Therapeutics, Inc. today announced that a Phase II trial of its oral recombinant salmon calcitonin in the prevention of postmenopausal osteoporosis was successfully concluded and yielded statistically significant, clinically relevant improvements in bone mineral density (BMD) at the lumbar spine. These data were presented at the American Society for Bone and Mineral Research (ASBMR) 2012 Annual Meeting by Phase II investigator Neil Binkley, MD, who is an Associate Professor of Endocrinology and Geriatrics at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin.1
The Phase II trial evaluated the ability of Tarsa’s oral calcitonin tablet to improve BMD at the lumbar spine in postmenopausal women with low bone mass (osteopenia) at increased risk of fracture. Tarsa’s oral calcitonin was superior to placebo in increasing BMD at the lumbar spine in this population, and its safety profile did not differ substantially from placebo.
“This is encouraging news for the millions of women with low bone mineral density at increased risk of fracture who currently have limited treatment options,” said Dr. Binkley. “The perceived safety issues with existing osteoporosis drugs have limited their use in this population, and there clearly is a need for additional agents.”
TAR01-201 was a randomized, double-blind proof-of-concept study comparing Tarsa’s oral recombinant salmon calcitonin to placebo in 129 postmenopausal women. The primary endpoint was the change in BMD at the lumbar spine over the course of the year-long study. The trial was conducted entirely in the US.
The Phase II results reinforce the findings of the Phase III ORACAL trial, which showed that Tarsa’s oral calcitonin demonstrated superiority to both placebo and nasal calcitonin spray in increasing BMD at the lumbar spine after 48 weeks in postmenopausal women with osteoporosis. In that study, the safety profile of Tarsa’s oral calcitonin did not differ substantially from nasal calcitonin or placebo. Tarsa is preparing to file an NDA for the use of its oral calcitonin in the treatment of postmenopausal osteoporosis in 2013.
“Our product has the potential to be the first FDA-approved oral formulation of calcitonin to be marketed as a treatment for postmenopausal osteoporosis, and we are pleased that it also appears to work well for osteoporosis prevention,” said David Brand, President and CEO of Tarsa. “We believe that our oral calcitonin could address an important unmet need for safe and effective therapies to prevent osteoporosis, and we are assessing options for conducting a Phase III registration trial.”
Tarsa also presented a poster at ASBMR 2012 assessing whether there was any sign of increased cancer risk in its two year-long trials of its oral calcitonin.2 The assessment concluded that the combined safety data from these clinical trials demonstrate no signal of carcinogenicity.
To conduct the assessment, Tarsa researchers integrated the safety databases from the two trials, which together included 694 women. The researchers reviewed all newly diagnosed adverse events in the trials consistent with malignancy. This absence of any carcinogenicity signal was consistent with previously conducted carcinogenicity, mutagenesis and chromosome aberration studies of Tarsa’s oral calcitonin, which had all been negative.
“Calcitonin has long enjoyed a reputation as a safe therapeutic, and we believe that our oral calcitonin is not associated with an increased risk of cancer,” concluded Dr. David Krause, Chief Medical Officer of Tarsa. “We plan to share our data with other interested parties and regulatory authorities to help ensure that decisions regarding the availability of calcitonin reflect all relevant information.”
Tarsa is developing its oral calcitonin under a licensing agreement with Unigene Laboratories that provides Tarsa with exclusive development and worldwide commercialization rights to Unigene’s oral calcitonin product, with the exception of China.
The American Society for Bone and Mineral Research 2012 Annual Meeting, the premier scientific meeting discussing the latest concepts and innovations in bone and mineral research, was held October 12-15, 2012 in Minneapolis, MN. For more information, visit www.asbmr.org/Meetings/AnnualMeeting.aspx.
1. “Safety and Efficacy of Orally Administered Recombinant Salmon Calcitonin Tablets in the Prevention of Postmenopausal Osteoporosis in Women with Low Bone Mass: a Phase 2 Placebo-Controlled Trial,” N Binkley MD, HG Bone MD, MA Bolognese MD, DS Krause MD. Presented at ASBMR 2012, Oct 15, 2012
2. “One Year Use of Oral Recombinant Salmon Calcitonin (rsCT) Is Not Associated with Increased Risk of Cancer,” D Krause MD, NAS Hernandez LPD, M Vitagliano, J Gilligan PhD, CE Buben MS. Presented at ASBMR 2012, Oct 15, 2012.
About Tarsa Therapeutics
Tarsa is developing a novel oral formulation of calcitonin for the treatment and prevention of postmenopausal osteoporosis. This product has the potential to be the first approved oral calcitonin, a natural hormone with a long history of safety and efficacy as an osteoporosis therapy. Tarsa is based in Philadelphia, PA. For more information, visit www.tarsatherapeutics.com
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