Tarsa Therapeutics reported progress in its two ongoing clinical development programs for its oral recombinant salmon calcitonin for the treatment and prevention of postmenopausal osteoporosis. Patient enrollment in the phase II osteoporosis prevention trial has been completed, and the full set of data from the phase III ORACAL trial has been accepted for an oral presentation at the American Society for Bone and Mineral Research (ASBMR) 2011 annual meeting in September. Separately, Tarsa also said it has closed an additional financing round that raised a total of $24.5 million.
Patient enrollment is now completed in TAR01-201, a double-blind phase II 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. Interim six-month data from this trial, which is being conducted entirely in the U.S., are expected to be available in early 2012.
Earlier this year, Tarsa reported that the phase III ORACAL trial of its oral recombinant salmon calcitonin in the treatment of postmenopausal osteoporosis had yielded statistically significant, positive top-line results. That protocol had been agreed to in a Special Protocol Assessment with the FDA and was subject to Scientific Advice from the European Medicines Agency. An NDA submission to the FDA is targeted for late 2011.
All of the company's existing investors participated in the latest financing, including MVM Life Science Partners, Quaker BioVentures, Novo and Unigene Laboratories. Tarsa plans to use the proceeds to advance the clinical development of its oral calcitonin.