R-Pharm JSC acquires rights to Tarsa’s TBRIA™, novel oral treatment for post-menopausal osteoporosis
Tarsa Therapeutics developed TBRIA™, a novel oral formulation of calcitonin for the treatment of postmenopausal osteoporosis in women greater than five years post menopause when alternative treatments are not suitable. This product has the potential to be the first approved oral calcitonin, a natural hormone with a long history of safety and efficacy as a treatment for osteoporosis.
TBRIA demonstrated positive safety and efficacy as a treatment for postmenopausal osteoporosis in the global, randomized, double-blind Phase 3 ORACAL trial. In the trial, TBRIA met its primary endpoint and demonstrated statistical superiority to both placebo and nasal calcitonin spray in increasing bone mineral density at the lumbar spine after 48 weeks of use. The safety profile of TBRIA did not substantially differ from nasal calcitonin or placebo.
Rights to TBRIA have been acquired by R-Pharm JSC, whose U.S. subsidiary is responsible for the continuing clinical development of TBRIA and subsequent regulatory submissions.