Tarsa Therapeutics today announced that the Phase III ORACAL trial of its oral recombinant salmon calcitonin in the treatment of postmenopausal osteoporosis was successfully concluded and yielded statistically significant, positive top-line results. The results will be used to support a New Drug Application (NDA) submission to the Food and Drug Administration (FDA) targeted for the fourth quarter of 2011, based on the study design and specific endpoints that were agreed with the FDA in a Special Protocol Assessment (SPA) agreement. By early 2012, Tarsa also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).
The ORACAL study is a Phase III multinational, randomized, double-blind, double-dummy, placebo-controlled trial of Tarsa's oral recombinant salmon calcitonin compared to commercially available, synthetic salmon calcitonin administered by nasal spray. The trial enrolled 565 postmenopausal women with established osteoporosis in six countries. The ORACAL study's primary endpoint was the percent change in lumbar spine bone mineral density (BMD) after one year of treatment. Success required that oral salmon calcitonin be superior to placebo and non-inferior to nasal salmon calcitonin spray in increasing BMD at the lumbar spine. Both results were positive and statistically significant. The trial also assessed the tolerability of oral calcitonin, which was similar to that of calcitonin administered by nasal spray and to placebo. The full data from the study are expected to be presented in a peer-reviewed forum later this year.
"With these positive Phase III top-line results in hand, we are proceeding with the additional dataset analyses we will need to submit an NDA to the FDA before the end of the year," said David Brand, President and CEO of Tarsa. "Our tablet has the potential to offer the 30-year record of safety and efficacy of calcitonin with the advantage of once-daily oral administration to the millions of postmenopausal women with osteoporosis. We believe that our product has the potential to be the first FDA-approved oral formulation of calcitonin to reach the market."
Separately, Tarsa announced that it has completed screening and has begun to randomize patients in its Phase II osteoporosis prevention trial. TAR01-201 is a double-blind study comparing Tarsa's oral recombinant salmon calcitonin to placebo in approximately 120 postmenopausal women who have low bone mass (osteopenia) and are at increased risk of fracture. This proof-of-concept study is evaluating the ability of oral calcitonin to prevent osteoporosis and maintain bone mass in this population. This trial, conducted entirely in the US, is expected to complete enrollment by the end of April 2011.
Dr. David Krause, Chief Medical Officer of Tarsa, commented, "Calcitonin has a long history of safety and efficacy as an osteoporosis therapy, and we believe that the availability of Tarsa's easy-to-use, once-daily oral calcitonin tablet would be welcomed by many healthcare providers and patients who are seeking additional osteoporosis treatment and prevention options, especially in view of continuing concerns about potential long-term safety issues with some other popular classes of osteoporosis drugs."
Calcitonin is approved for the treatment and prevention of postmenopausal osteoporosis, but its use has been limited by the fact that it is currently available only in intranasal and injectable forms. Tarsa's oral calcitonin product has been shown in prior clinical studies to deliver the desired blood levels of calcitonin and reduce levels of biomarkers of bone resorption.