Tarsa reports positive data from OSTORA Phase III ORACAL trial for postmenopausal osteoporosis

Sep 19 2011

Tarsa Therapeutics today reported that it presented positive safety and efficacy data from its Phase III ORACAL trial of OSTORA™, the company's oral recombinant salmon calcitonin tablet in development for the treatment of postmenopausal osteoporosis.  These data were presented at the American Society for Bone and Mineral Research 2011 Annual Meeting by ORACAL investigator Neil Binkley, MD, who is an Associate Professor of Endocrinology and Geriatrics at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin.

The ORACAL study was a Phase III multinational, randomized, double-blind, double-dummy, placebo controlled trial of Tarsa's oral recombinant salmon calcitonin compared to placebo and to commercially available, synthetic salmon calcitonin administered by nasal spray.  The trial enrolled 565 postmenopausal women in six countries with established osteoporosis.

Earlier this year, Tarsa reported top-line efficacy and safety results from the ORACAL trial.  The data reported today 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.  

"These are encouraging results that may be of particular relevance for the women with osteoporosis who are reluctant to take or unable to tolerate currently available treatments," said Dr. Binkley.  "Potential safety issues with current drug therapies, while rare, have led some osteoporosis patients to discontinue therapy or avoid beginning treatment.  Calcitonin has a long history of safety for postmenopausal osteoporosis treatment, and potential availability of this once-daily oral formulation could make it a useful new option for osteoporosis patients and their physicians."

According to the International Osteoporosis Foundation, studies indicate that up to half of osteoporosis patients stop their treatment after just one year.  In one study, two-thirds of osteoporosis patients said their medication interfered with their lives in some way and over 20% of the women who missed or stopped their treatment said it was due to side effects.

"The encouraging efficacy and safety data presented at the ASBMR meeting, including data showing that OSTORA demonstrated superior efficacy to nasal calcitonin, reinforces our view that OSTORA has the potential to address an unmet need in current therapy," noted David Krause, MD, Chief Medical Officer of Tarsa.  "Data suggest that approximately two million women in the U.S. alone have discontinued osteoporosis treatment for various reasons, which include poor tolerance or the perceived risk of adverse effects, leaving them more vulnerable to potentially disabling fractures.  Reports from the field suggest many other newly diagnosed osteoporosis patients have not started drug treatment as a result of safety concerns.  The data presented today indicate that once-daily OSTORA may have the potential to provide an effective, safe and convenient new option for these millions of women and their physicians."

Calcitonin is 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.  Prior clinical studies show that Tarsa's oral calcitonin tablet delivers calcitonin effectively and reduces blood levels of bone resorption biomarkers.

"We view the new OSTORA data presented today as very promising news for osteoporosis patients and their physicians seeking additional treatment options," said David Brand, President and CEO of Tarsa.  "We look forward to filing a New Drug Application for OSTORA with the Food and Drug Administration and to submitting a Marketing Authorization Application to the European Medicines Agency thereafter.  We also are advancing our ongoing Phase Il trial in osteoporosis prevention, an indication for which our oral calcitonin could be especially relevant."

Tarsa's oral calcitonin is also being assessed in a double-blind Phase II study comparing the OSTORA tablet to placebo in 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.  

Tarsa is developing its OSTORA oral calcitonin under a licensing agreement with Unigene Laboratories that provides Tarsa with exclusive development and worldwide commercialization rights to Unigene's oral calcitonin product, with the exception of China.  For more information on Unigene, see www.unigene.com.

The American Society for Bone and Mineral Research 2011 Annual Meeting, the premier scientific meeting discussing the latest concepts and innovations in bone and mineral research, is being held September 16-20, 2011 in San Diego, California.