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 have been reported in Tarsa’s global randomized Phase III ORACAL trial evaluating the safety and efficacy of its OSTORA™ recombinant oral salmon calcitonin (rsCT) in postmenopausal women with osteoporosis. The full data from the study were presented at the American Society for Bone and Mineral Research 2011 Annual Meeting.  The Phase III data show that OSTORA achieved all of the efficacy endpoints in the trial and indicate that the safety profile of OSTORA did not substantially differ from nasal calcitonin or placebo.  The majority of adverse events were mild or moderate, and OSTORA was also significantly less immunogenic than nasal calcitonin spray.

The OSTORA trial was a double-blind study comparing the safety and efficacy of Tarsa’s OSTORA oral rsCT to that of synthetic salmon CT administered via the nasal route, and to placebo. The ORACAL trial was designed to serve as the pivotal efficacy trial for regulatory authorities.  It enrolled 565 patients and included study sites in the United States, United Kingdom, Poland, Hungary, Bulgaria and South Africa. The ORACAL trial design was highlighted in a poster presentation at Clinical Osteoporosis 2010, a symposium jointly sponsored by the International Society for Clinical Densitometry and the National Osteoporosis Foundation. Full data from the study were presented at the American Society for Bone and Mineral Research 2011 Annual Meeting. The primary efficacy endpoint in this one-year trial was the change in bone mineral density at the lumbar spine. 

Tarsa plans to submit a New Drug Application to the US Food and Drug Administration (FDA) for the use of its OSTORA 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. Tarsa also plans to submit a Marketing Authorization Application to the European Medicines Agency thereafter.

OSTEOPOROSIS PREVENTION PROGRAM

A Phase II trial evaluating Tarsa’s once-daily oral calcitonin for the prevention of postmenopausal osteoporosis is underway.  Learn more about the trial here. Patient screening has been completed, and trial enrollment is expected to be complete by the end of April 2011. 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 the efficacy of Tarsa’s OSTORA™ oral calcitonin in the prevention of bone loss in these women, as well as its safety and tolerability.  This trial will also explore the optimal dosing regimen for OSTORA 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 nighttime administration would be ideal for an anti-resorptive agent such as calcitonin.

The Phase II prevention trial is being conducted at multiple centers in the US.