Tarsa Therapeutics, Inc. announced completion of its global phase III ORACAL trial testing the company’s once-daily oral recombinant calcitonin for the treatment of postmenopausal osteoporosis.  Results from the ORACAL trial are expected in early spring.  In addition, Tarsa announced initiation of a new phase II study of its oral calcitonin for the prevention of postmenopausal osteoporosis.  

The ORACAL study is a multinational, randomized, double-blind, active and placebo-controlled phase III trial that enrolled 565 postmenopausal women with osteoporosis.  Analysis of the trial data is currently underway.

The new phase II prevention trial is a randomized, double-blind, placebo-controlled study designed to enrol approximately 120 postmenopausal women with low bone mass at increased risk of fracture.  The trial will assess the efficacy of Tarsa’s oral calcitonin in the prevention of bone loss in these women, as well as its safety and tolerability.  The prevention trial is being conducted at multiple centres in the US.

“The conclusion of our phase III ORACAL osteoporosis treatment trial and initiation of our phase II prevention trial are major milestones in Tarsa’s oral calcitonin programme,” said David Brand, president and CEO of Tarsa.  “Our tablet has the potential to offer calcitonin’s 30-year record of safety and efficacy with the advantage of once-daily oral administration to the millions of postmenopausal women with osteoporosis or at risk of osteoporosis.  We look forward to releasing ORACAL safety and efficacy data in the coming months.  If positive, we believe that our product has the potential to be the first FDA-approved oral formulation of calcitonin to reach the market.”  

Tarsa plans to submit a New Drug Application to the US Food and Drug Administration for the use of its oral calcitonin as a treatment for postmenopausal osteoporosis later this year, and a Marketing Authorization Application to the European Medicines Agency next year.

Calcitonin is currently approved for the treatment 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.

Dr David Krause, chief medical officer of Tarsa, commented, “Osteoporosis is a common condition that poses major health risks to individuals as they age, but it can be both treated and prevented.  Calcitonin has a long history of safety and efficacy as an osteoporosis therapy, and we believe the availability of Tarsa’s easy-to-use, once-daily oral calcitonin tablet will be welcomed by the many health care providers and patients seeking additional treatment options, especially in view of continuing concerns about potential long-term safety issues with other popular classes of osteoporosis drugs.”

Tarsa’s phase II prevention trial will also explore the optimal dosing regimen for oral calcitonin by administering the tablets either with the evening meal or at bedtime.  Calcitonin helps maintain bone mass by acting on osteoclasts to limit bone resorption.  Most bone resorption occurs while individuals are sleeping; therefore some researchers believe that night time administration would be ideal for an anti-resorptive agent such as calcitonin.

Tarsa Therapeutics is developing an oral formulation of calcitonin for the treatment and prevention of postmenopausal osteoporosis.  Calcitonin has a long history of safety and efficacy, and availability of an oral form is expected to generate wider use.