Tarsa Therapeutics reported positive data from a Phase III study evaluating its once-daily oral recombinant salmon calcitonin in the treatment of postmenopausal osteoporosis. The Orcal study results confirmed the equivalence of oral calcitonin to a nasal spray calcitonin in terms of improvements in bone mineral density (BMD) after a year of treatment. The study data will be used to support an NDA application to FDA, likely by year-end. A marketing authorization application submission to the European regulatory agency is projected by early 2012.
Tarsa is developing the oral calcitonin under an exclusive worldwide (excluding China) development and commercialization agreement with Unigene, signed in 2009.
The international Orcal study compared the effects on bone mineral density of treatment using Tarsa’s oral recombinant salmon calcitonin tablet with a synthetic salmon calcitonin administered by nasal spray. More than 560 postmenopausal women with established osteoporosis were enrolled. The results showed Tarsa’s oral calcitonin was at least as good as the nasal salmon calcitonin spray in terms of increasing bone mineral density at the lumbar spine and was equally tolerable.
“We believe that our product has the potential to be the first FDA-approved oral formulation of calcitonin to reach the market,” remarks David Brand, Tarsa’s president and CEO. “Our tablet has the potential to offer the 30-year record of safety and efficacy of calcitonin with the advantage of once-daily oral administration to the millions of postmenopausal women with osteoporosis.”
Announcement of the Phase III Orcal study data coincided with Tarsa confirming that it has also started to randomize patients into a U.S.-based placebo-controlled Phase II osteoporosis prevention study, TAR01-201, which will enroll about 120 postmenopausal women with low bone mass and an increased risk of fracture.
Unigene developed the oral peptide delivery platform on which the oral calcitonin product is based. The firm claims the Phase III trial results validate its delivery techology and recombinant manufacturing capabilities. “Furthermore, these results give added confidence for our ongoing development programs and feasibility studies using our proprietary oral drug delivery technology,” comments Nozer Mehta, Ph.D., vp for biological R&D at Unigene.
Unigene is exploiting its Peptelligence peptide delivery and E. coli manufacturing technologies to develop orally or nasally administered peptide-based drugs The firm’s first product to reach the market, Fortical®, is a nasal spray calcitonin that received FDA approval in 2005 for the treatment of postmenopausal osteoporosis.
Earlier this month Unigene started a Phase II study evaluating its oral recombinant parthyroid hormone (PTH) candidate for the treatment of postmenopausal women. The drug has been partnered with GlaxoSmithkline (GSK), and under terms of the agreement, which was amended in December 2010, Unigene is responsible for carrying out the Phase II trial. The firm received a $4 million payment from GSK to cover the costs of the study, and will receive another $4 million on completion of patient enrollment. Dependent on the Phase II results, GSK may then elect to take over all future development and commercialization of the product. Unigene could potentially receive another $142 million in regulatory and commercialization milestones.
Tarsa Therapeutics was established in 2009 with a $24 million investment by three life science venture capital funds, to develop the oral calcitonin product. Unigene holds a roughly 25% stake in Tarsa.