Tarsa Therapeutics Overview

Tarsa Therapeutics, Inc. was founded in 2009 with the goal of developing innovative therapies for the treatment and prevention of osteoporosis and related bone diseases. Tarsa is developing TBRIA™ an oral formulation of salmon calcitonin, which is a peptide hormone that inhibits bone resorption, a key process underlying the development of osteoporosis.

An oral form of calcitonin has the potential to offer patients a proven therapeutic with easier administration and enhanced long-term compliance.

Injectable and intranasal formulations of calcitonin have been used for the treatment of osteoporosis for more than 35 years. Tarsa’s unique, once-daily oral calcitonin tablet, TBRIA, is designed to offer osteoporosis patients the advantage of easier administration, room temperature storage and the potential for enhanced long-term compliance. Positive safety and efficacy data for TBRIA in the treatment of postmenopausal osteoporosis were demonstrated in the Phase III ORACAL clinical trial, and the results were published in the Journal of Bone and Mineral Research (JBMR)[1]. This trial, which was the subject of a Special Protocol Assessment with the FDA, is the pivotal Phase III study that forms the basis for Tarsa’s NDA, which was accepted for filing by the FDA in October, 2015. Tarsa has also completed a successful trial in postmenopausal women with low bone mass, or osteopenia. [2].

Tarsa’s formulation of TBRIA uses patented oral delivery technology licensed from Enteris Biopharma, a successor company to Unigene Laboratories. Tarsa has exclusive development and worldwide commercialization rights to the oral calcitonin product developed with Enteris’ technology, with the exception of China. Tarsa is located in downtown Philadelphia and is led by an experienced team of biopharmaceutical executives.

[1] Binkley N, Bolognese M, Sidorowicz-Bialynicka A, et al. A Phase 3 Trial of the Efficacy and Safety of Oral Recombinant Calcitonin: The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) Trial. J Bone Miner Res 2012, 27:1821–1829

[2] Binkley N, Bone H, Gilligan JP, Krause D. Efficacy and safety of oral recombinant salmon calcitonin tablets in postmenopausal women with low bone mass and increased fracture risk: a randomized, placebo-controlled trial.  Osteopor Int 2014. DOI 10.1007/s00198-014-2796-0