Tarsa Completes Phase III Oral Calcitonin Trial

Tarsa Therapeutics, Inc. has completed its global Phase III ORACAL trial with once-daily oral recombinant calcitonin for the treatment of postmenopausal osteoporosis. The multinational, randomized, double-blind, active and placebo-controlled Phase III trial enrolled 565 postmenopausal women with osteoporosis. Calcitonin, an anti-resorptive agent, has been shown to help maintain bone mass by acting on osteoclasts to limit bone resorption.

Tarsa has also initiated a new Phase II study of oral calcitonin for the prevention of postmenopausal osteoporosis. The Phase II prevention trial is a randomized, double-blind, placebo-controlled study designed to enroll approximately 120 postmenopausal women with low bone mass at increased risk of fracture.The trial will assess efficacy in the prevention of bone loss, as well as safety and tolerability.

Tarsa plans to submit a NDA to the FDA for the use of its oral calcitonin as a treatment for postmenopausal osteoporosis later this year, and a MAA to the European Medicines Agency next year.

Calcitonin is currently approved for the treatment of postmenopausal osteoporosis, but its use has been limited because it’s currently available only in intranasal and injectable forms. Tarsa’s oral calcitonin product has been shown to deliver the desired blood levels of calcitonin and reduce levels of biomarkers of bone resorption.