Emisphere Technologies Inc. has announced that Novartis Pharma AG and its development partner Nordic Bioscience have notified Emisphere of the initiation of a phase III clinical trial for the treatment of osteoporosis with an oral form of salmon calcitonin (referred to as SMC021), a new drug candidate, using Emisphere's eligen delivery technology.
As a result of the initiation of the trial, Emisphere will receive a milestone payment from Novartis. The use of Emisphere's novel eligen technology reflects the potential that for the first time salmon calcitonin may also be available as a convenient oral medication, rather than the currently available injectable or intranasal options.
Osteoporosis is a disease that reduces the density and quality of bone and worldwide affects an estimated 75 million people in Europe, the United States and Japan. The phase III trial, which will include more than 4,500 osteoporosis patients in Europe, US, China and Latin America, is a three year, randomised, multi-centre, placebo-controlled study to evaluate the safety and efficacy of oral calcitonin.
"Oral calcitonin has potential to be a novel oral treatment option in the fight against osteoporosis," said Lewis H. Bender, president and CEO of Emisphere. "We are very excited about the opportunity to be in phase III with Novartis and their development partner Nordic Bioscience. Emisphere has a long working relationship with Novartis on oral calcitonin and we believe that this study is an important confirmation of the Emisphere eligen technology."
To reach this point, initiation of this phase III study, Novartis has conducted extensive safety testing on both the oral calcitonin product and the Emisphere technology. There has been a phase II study, several phase I clinical trials and extensive pre clinical safety studies conducted. Carrier and drug product materials have been produced at large scale and also tested in clinical trials.
Novartis has received CHMP advice on the phase III trial design and clearance from FDA to proceed with phase III study under a special protocol assessment. Nordic Bioscience following a development agreement with Novartis is conducting the clinical trial.
Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland. Calcitonin enables the bone to retain more of its mass and functionality by inhibiting the bone-tissue resorbing activity of specialized bone cells called osteoclasts.