The study is being conducted by Nordic Bioscience both in the European Union and in the US, and is planned to include more than 2000 patients.
Calcitonin is a natural hormone secreted by the thyroid gland that is important for bone formation and maintenance. It helps regulate normal blood calcium levels and inhibitors cells that are responsible for bone degradation. Calcitonin derived from salmon is estimated to be about 30 times more potent than the human version.
Synthetic salmon calcitonin, which is identical to the natural salmon calcitonin, is currently available only as nasal spray or as an injectable therapy. Emisphere’s technology creates the potential for salmon calcitonin to be available as a convenient oral medication for the first time.
“We are pleased to announce the initiation of phase III trials for oral calcitonin, which may represent the first disease-modifying drug for the treatment of osteoarthritis,” said Michael Novinski, president and CEO of Emisphere. “Currently, there are no available treatment options for osteoarthritis that actually help prevent disease progression or joint damage, and we are excited to be at the leading edge of research in this area.”
In 2000, Emisphere and Novartis Pharma entered into a license agreement for the development of oral salmon calcitonin for the treatment of osteoarthritis and osteoporosis. The phase III clinical trial of oral calcitonin for the treatment in osteoporosis started also early this year.