Emisphere Technologies, Inc announced that Novartis Pharma AG and Nordic Bioscience have initiated a second multi-centre phase-III study exploring the safety and efficacy of an oral formulation of salmon calcitonin using Emisphere's proprietary Eligen Technology to treat patients with osteoarthritis of the knee. This second study, designed to meet FDA requirements for US registration, will examine patients between 51 and 80 years old suffering from painful symptoms of knee osteoarthritis. The study will be conducted in multiple sites, including the U.S., with an estimated completion during the second half of 2011.
"This second phase-III study is a significant step in facilitating the commercialization of oral salmon calcitonin in combination with our Eligen drug delivery technology in the US and worldwide," said Michael V Novinski, president and chief executive officer of Emisphere. "This combination may provide a solution to the growing problem of osteoarthritis."
Osteoarthritis is the most common form of arthritis. OA is characterized by low-grade inflammation resulting in joint pain that is caused by a wearing-away of cartilage that cushions the joints and the destruction or decrease of synovial fluid that lubricates those joints. As OA progresses, pain can result when patients walk, stand, or when their weight is borne by the affected joints. OA affects nearly 21 million people in the United States, accounting for 25% of visits to primary care physicians and half of all non-steroidal anti-inflammatory drug prescriptions. It is estimated that 80% of the population will have radiographic evidence of OA by age 65.
Emisphere is a biopharmaceutical company that focuses on a unique and improved delivery of therapeutic molecules using its Eligen Technology.