Tarsa Therapeutics' OSTORA™ recombinant oral salmon calcitonin achieved its safety and efficacy endpoints in the Phase III ORACAL trial.
OSTEOPOROSIS TREATMENT PROGRAM
Positive safety and efficacy results were reported in Tarsa’s global randomized Phase III ORACAL trial evaluating the safety and efficacy of its recombinant oral salmon calcitonin in postmenopausal women with osteoporosis. Tarsa’s oral calcitonin achieved all of the efficacy endpoints in the trial, demonstrating superiority to both placebo and nasal calcitonin spray in increasing bone mineral density at the lumbar spine after 48 weeks in postmenopausal women with osteoporosis. In the trial, the safety profile of oral calcitonin did not substantially differ from nasal calcitonin or placebo. The majority of adverse events were mild or moderate, and oral calcitonin was significantly less immunogenic than nasal calcitonin spray.
The ORACAL trial was a randomized, double-blind study comparing the safety and efficacy of Tarsa’s recombinant oral salmon calcitonin to synthetic salmon calcitonin administered via the nasal route and to placebo. It was designed to serve as the pivotal efficacy trial for regulatory authorities and enrolled 565 patients at study sites in the United States, United Kingdom, Poland, Hungary, Bulgaria and South Africa. Full data from the trial were presented at the American Society for Bone and Mineral Research 2011 Annual Meeting and published in the August 2012 edition of the Journal of Bone and Mineral Research*.
Tarsa is preparing to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the use of its oral calcitonin as a treatment for postmenopausal osteoporosis, based on the study design and specific endpoints that were agreed with the FDA in a Special Protocol Assessment agreement.
* A Phase 3 Trial of the Efficacy and Safety of Oral Recombinant Calcitonin: The Oral Calcitonin in
Postmenopausal Osteoporosis (ORACAL) Trial, N Binkley, M Bolognese, A Sidorowicz-Bialynicka , T Vally, R Trout, C Miller, C E Buben, J P Gilligan, and DS Krause, Journal of Bone and Mineral Research, DOI: 10.1002/jbmr.1602 (p. 1821-1829)
Postmenopausal Osteoporosis (ORACAL) Trial, N Binkley, M Bolognese, A Sidorowicz-Bialynicka , T Vally, R Trout, C Miller, C E Buben, J P Gilligan, and DS Krause, Journal of Bone and Mineral Research, DOI: 10.1002/jbmr.1602 (p. 1821-1829)
OSTEOPOROSIS PREVENTION PROGRAM
Tarsa has completed a successful Phase II trial of its once-daily oral calcitonin in the prevention of postmenopausal osteoporosis. The Phase II prevention trial was a randomized, double-blind, placebo-controlled study designed to evaluate the ability of Tarsa’s oral calcitonin tablet to improve bone mineral density at the lumbar spine in postmenopausal women with low bone mass (osteopenia), who are 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.
The Phase II prevention trial was conducted at multiple clinical centers in the US. The results of this trial were presented at the American Society for Bone and Mineral Research 2012 Annual Meeting.